Trial Outcomes & Findings for AGN-Cogni.Q Acute Dose Safety and Pharmacokinetics Dose-Response in Prostate Cancer Patients (NCT NCT05375539)
NCT ID: NCT05375539
Last Updated: 2026-05-06
Results Overview
Evaluation of cardiac rhythm and repolarization using 12-lead EKG to identify any treatment-emergent abnormalities. Unit of Measure: Number of participants with treatment-emergent EKG abnormalities.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Baseline (pre-dose) and 5 hours post-dose on each dosing day and at 24 hours (Up to 5 weeks).
Results posted on
2026-05-06
Participant Flow
This was a sequential within-subject dose-escalation study. Twelve participants received the 800 mg dose. Two participants discontinued after this period due to adverse events and did not proceed to higher doses. Ten participants continued to the 1200 mg and 1600 mg doses. Five participants enrolled during the escalation stage proceeded to the 2000 mg dose.
Participant milestones
| Measure |
AGN-CognI.Q
Dose level +1 (800 mg, 4 CognI.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +2 (1,200 mg, 6 CognI.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +3 (1,600 mg, 8 CognI.Q capsules, Fast at least 2 h before dose and 1 h after)
AGN-CognI.Q: Herbal dietary supplement products containing/based on AGN alcoholic extracts (including CognI.Q; Decursinol-50TM, GWB78®, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin) are marketed in the US for memory enhancement, pain relief and for women's post-menopausal symptom management.
|
|---|---|
|
Dose 800 mg
STARTED
|
12
|
|
Dose 800 mg
COMPLETED
|
12
|
|
Dose 800 mg
NOT COMPLETED
|
0
|
|
Dose 1200 mg
STARTED
|
10
|
|
Dose 1200 mg
COMPLETED
|
10
|
|
Dose 1200 mg
NOT COMPLETED
|
0
|
|
Dose 1600 mg
STARTED
|
10
|
|
Dose 1600 mg
COMPLETED
|
10
|
|
Dose 1600 mg
NOT COMPLETED
|
0
|
|
Dose 2000 mg
STARTED
|
5
|
|
Dose 2000 mg
COMPLETED
|
5
|
|
Dose 2000 mg
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AGN-Cogni.Q Acute Dose Safety and Pharmacokinetics Dose-Response in Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
AGN-Cogni.Q Escalation Group
n=12 Participants
Dose level +1 (800 mg, 4 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +2 (1,200 mg, 6 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +3 (1,600 mg, 8 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +3 (2000 mg, 10 Cogni.Q capsules, Fast at least 2 h before dose and 1 h after)
AGN-Cogni.Q: Herbal dietary supplement products containing/based on AGN alcoholic extracts (including Cogni.Q; Decursinol-50TM, GWB78®, Ache Action, Fast-Acting Joint Formula, EstroG-100/Profemin) are marketed in the US for memory enhancement, pain relief and for women's post-menopausal symptom management.
|
|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 6.5 • n=54 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-dose) and 5 hours post-dose on each dosing day and at 24 hours (Up to 5 weeks).Population: This was a sequential within-subject dose-escalation study. Arms are defined by dose level. Participants could contribute data to multiple arms due to the within-subject dose-escalation design.
Evaluation of cardiac rhythm and repolarization using 12-lead EKG to identify any treatment-emergent abnormalities. Unit of Measure: Number of participants with treatment-emergent EKG abnormalities.
Outcome measures
| Measure |
AGN-CognI.Q 800 mg
n=12 Participants
Participants receiving 800 mg (4 capsules) under fasting conditions.
|
AGN-CognI.Q 1200 mg
n=10 Participants
Participants receiving 1200 mg (6 capsules) under fasting conditions.
|
AGN-CognI.Q 1600 mg
n=10 Participants
Participants receiving 1600 mg (8 capsules) under fasting conditions.
|
AGN-CognI.Q 2000 mg
n=5 Participants
Participants receiving 2000 mg (10 capsules) under fasting conditions.
|
|---|---|---|---|---|
|
Cardiac Safety Via Electrocardiography (EKG)
Participants with ≥1 treatment-emergent EKG abnormality
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cardiac Safety Via Electrocardiography (EKG)
Participants with no treatment-emergent EKG abnormality
|
12 Participants
|
10 Participants
|
10 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-dose and prior to each subsequent dose level (Up to 5 weeks).Population: This was a single-arm sequential dose-escalation study. Participants received escalating single doses of AGN-CognI.Q (800 mg, 1200 mg, 1600 mg, and 2000 mg). Outcome measures were summarized across all dose levels because the same participants could contribute data at multiple dose levels.
Evaluation of hematological and metabolic safety via Complete Blood Count (CBC) with differential, Comprehensive Metabolic Panel (CMP), and coagulation tests (INR, PT, PTT) to identify any treatment-emergent abnormalities.
Outcome measures
| Measure |
AGN-CognI.Q 800 mg
n=12 Participants
Participants receiving 800 mg (4 capsules) under fasting conditions.
|
AGN-CognI.Q 1200 mg
n=10 Participants
Participants receiving 1200 mg (6 capsules) under fasting conditions.
|
AGN-CognI.Q 1600 mg
n=10 Participants
Participants receiving 1600 mg (8 capsules) under fasting conditions.
|
AGN-CognI.Q 2000 mg
n=5 Participants
Participants receiving 2000 mg (10 capsules) under fasting conditions.
|
|---|---|---|---|---|
|
Safety Blood Laboratory Tests
Participants with Coagulation abnormalities (INR/aPTT)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety Blood Laboratory Tests
Participants with Metabolic abnormalities (Hypokalemia)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-dose for each dosing visit (Up to 5 weeks)Population: This was a single-arm sequential dose-escalation study in which participants received escalating single doses of AGN-CognI.Q (800, 1200, 1600, and 2000 mg). Twelve participants received the 800 mg dose; two discontinued due to adverse events and did not proceed to higher doses. PK results include only participants with evaluable PK samples: n=10 (800-1600 mg) and n=5 (2000 mg).
To determine the Cmax for decursin (D), decursinol angelate (DA), and their metabolite decursinol (DOH) following a single dose. Peak concentration is estimated from blood samples collected at 0, 2, 3, 4, 5, 6, 7, and 24 hours post-dose.
Outcome measures
| Measure |
AGN-CognI.Q 800 mg
n=10 Participants
Participants receiving 800 mg (4 capsules) under fasting conditions.
|
AGN-CognI.Q 1200 mg
Participants receiving 1200 mg (6 capsules) under fasting conditions.
|
AGN-CognI.Q 1600 mg
Participants receiving 1600 mg (8 capsules) under fasting conditions.
|
AGN-CognI.Q 2000 mg
Participants receiving 2000 mg (10 capsules) under fasting conditions.
|
|---|---|---|---|---|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Decursinol DOH - 800 mg dose
|
736.9 ng/mL
Standard Deviation 211.4
|
—
|
—
|
—
|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Decursinol DOH - 1200 mg dose
|
962.4 ng/mL
Standard Deviation 323.2
|
—
|
—
|
—
|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Decursinol DOH - 1600 mg dose
|
1525.7 ng/mL
Standard Deviation 514.3
|
—
|
—
|
—
|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Decursinol angelate DA - 1600 mg dose
|
87.9 ng/mL
Standard Deviation 89.0
|
—
|
—
|
—
|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Decursinol angelate DA - 2000 mg dose
|
92.8 ng/mL
Standard Deviation 102.2
|
—
|
—
|
—
|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Decursin D - 800 mg dose
|
2.63 ng/mL
Standard Deviation 1.48
|
—
|
—
|
—
|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Decursin D - 2000 mg dose
|
7.19 ng/mL
Standard Deviation 4.10
|
—
|
—
|
—
|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Decursinol DOH - 2000 mg dose
|
1999.6 ng/mL
Standard Deviation 486.5
|
—
|
—
|
—
|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Decursinol angelate DA - 800 mg dose
|
35.5 ng/mL
Standard Deviation 42.7
|
—
|
—
|
—
|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Decursinol angelate DA - 1200 mg dose
|
49.8 ng/mL
Standard Deviation 56.7
|
—
|
—
|
—
|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Decursin D - 1200 mg dose
|
3.83 ng/mL
Standard Deviation 1.67
|
—
|
—
|
—
|
|
Pharmacokinetics: Peak Plasma Concentration (Cmax) of D, DA, and DOH
Decursin D - 1600 mg dose
|
9.47 ng/mL
Standard Deviation 7.95
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-dose for each dosing visit (Up to 5 weeks)Population: This was a single-arm sequential dose-escalation study in which participants received escalating single doses of AGN-CognI.Q (800, 1200, 1600, and 2000 mg). Outcomes were summarized across doses because participants could contribute data at multiple dose levels. PK-evaluable subjects completed the 24-hour PK sampling: n=12 (800 mg), n=10 (1200 and 1600 mg), and n=5 (2000 mg).
Area under the plasma concentration-time curve from time zero to 24 hours (AUC0-24h) for decursin (D), decursinol angelate (DA), and their metabolite decursinol (DOH). AUC is calculated using the trapezoidal rule from blood samples collected at 0, 2, 3, 4, 5, 6, 7, and 24 hours post-dose.
Outcome measures
| Measure |
AGN-CognI.Q 800 mg
n=10 Participants
Participants receiving 800 mg (4 capsules) under fasting conditions.
|
AGN-CognI.Q 1200 mg
Participants receiving 1200 mg (6 capsules) under fasting conditions.
|
AGN-CognI.Q 1600 mg
Participants receiving 1600 mg (8 capsules) under fasting conditions.
|
AGN-CognI.Q 2000 mg
Participants receiving 2000 mg (10 capsules) under fasting conditions.
|
|---|---|---|---|---|
|
Plasma Concentration Versus Time Curve (AUC)
Decursinol DOH - 1600 mg dose
|
16,413 ng*h/mL
Standard Deviation 9,537
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Curve (AUC)
Decursinol DOH - 2000 mg dose
|
23,019 ng*h/mL
Standard Deviation 7,838
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Curve (AUC)
Decursinol angelate DA - 800 mg dose
|
278 ng*h/mL
Standard Deviation 335
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Curve (AUC)
Decursinol angelate DA - 1200 mg dose
|
348 ng*h/mL
Standard Deviation 446
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Curve (AUC)
Decursinol angelate DA - 1600 mg dose
|
650 ng*h/mL
Standard Deviation 767
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Curve (AUC)
Decursinol angelate DA - 2000 mg dose
|
708 ng*h/mL
Standard Deviation 1015
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Curve (AUC)
Decursin D - 800 mg dose
|
28.2 ng*h/mL
Standard Deviation 17.5
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Curve (AUC)
Decursin D - 1200 mg dose
|
36.4 ng*h/mL
Standard Deviation 14.7
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Curve (AUC)
Decursin D - 1600 mg dose
|
67.8 ng*h/mL
Standard Deviation 46.7
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Curve (AUC)
Decursin D - 2000 mg dose
|
66.0 ng*h/mL
Standard Deviation 39.3
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Curve (AUC)
Decursinol DOH - 800 mg dose
|
8,069 ng*h/mL
Standard Deviation 3,372
|
—
|
—
|
—
|
|
Plasma Concentration Versus Time Curve (AUC)
Decursinol DOH - 1200 mg dose
|
10,577 ng*h/mL
Standard Deviation 5,007
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (0 hours) and Day 2 (24 hours post-dose).Population: This was a sequential within-subject dose-escalation study. Results are presented by dose level. The number of participants analyzed was n=10 for 800, 1200, and 1600 mg, and n=5 for 2000 mg. Participants could contribute data to multiple dose groups.
The percentage of specific immune cell populations (NK cells, CD4+ T cells, and CD8+ T cells) within the total lymphocyte pool was measured using flow cytometric quantitation. Change is evaluated by comparing blood samples taken at Baseline (0h) to Day 2 (24 hours ± 2 hours) following administration of each AGN-CognI.Q dose.
Outcome measures
| Measure |
AGN-CognI.Q 800 mg
n=10 Participants
Participants receiving 800 mg (4 capsules) under fasting conditions.
|
AGN-CognI.Q 1200 mg
n=10 Participants
Participants receiving 1200 mg (6 capsules) under fasting conditions.
|
AGN-CognI.Q 1600 mg
n=10 Participants
Participants receiving 1600 mg (8 capsules) under fasting conditions.
|
AGN-CognI.Q 2000 mg
n=5 Participants
Participants receiving 2000 mg (10 capsules) under fasting conditions.
|
|---|---|---|---|---|
|
Change From Baseline in NK, CD4+ T, and CD8+ T Cell Percentages at 24 Hours.
Total CD8+ T Cells Post-dose
|
13.2 Percentage
Standard Deviation 5.79
|
12.7 Percentage
Standard Deviation 7.31
|
12.4 Percentage
Standard Deviation 6.44
|
12.5 Percentage
Standard Deviation 8.34
|
|
Change From Baseline in NK, CD4+ T, and CD8+ T Cell Percentages at 24 Hours.
Total CD4+ T Cells Pre-dose
|
36.6 Percentage
Standard Deviation 8.47
|
37.1 Percentage
Standard Deviation 8.47
|
37.6 Percentage
Standard Deviation 8.47
|
38.1 Percentage
Standard Deviation 8.47
|
|
Change From Baseline in NK, CD4+ T, and CD8+ T Cell Percentages at 24 Hours.
Total CD4+ T Cells Post-dose
|
36.8 Percentage
Standard Deviation 8.47
|
37.4 Percentage
Standard Deviation 8.47
|
37.9 Percentage
Standard Deviation 8.47
|
38.4 Percentage
Standard Deviation 8.47
|
|
Change From Baseline in NK, CD4+ T, and CD8+ T Cell Percentages at 24 Hours.
Total CD8+ T Cells Pre-dose
|
13.3 Percentage
Standard Deviation 7.38
|
12.3 Percentage
Standard Deviation 5.47
|
12.8 Percentage
Standard Deviation 5.59
|
12.8 Percentage
Standard Deviation 7.85
|
|
Change From Baseline in NK, CD4+ T, and CD8+ T Cell Percentages at 24 Hours.
Total NK Cells Pre-dose
|
18.6 Percentage
Standard Deviation 8.61
|
19.6 Percentage
Standard Deviation 9.01
|
19.2 Percentage
Standard Deviation 7.46
|
17.4 Percentage
Standard Deviation 10.9
|
|
Change From Baseline in NK, CD4+ T, and CD8+ T Cell Percentages at 24 Hours.
Total NK Cells Post-Dose
|
19.9 Percentage
Standard Deviation 7.49
|
19.8 Percentage
Standard Deviation 8.15
|
18.4 Percentage
Standard Deviation 8.04
|
19 Percentage
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: Baseline (0 hours) and 24 hours post-dose.Population: This was a single-arm sequential dose-escalation study in which participants received escalating single doses of AGN-CognI.Q (800, 1200, 1600, and 2000 mg). Results were summarized across dose levels because the same participants could contribute data at multiple doses. The analysis includes subjects with evaluable temperature measurements at baseline and post-dose time points.
Body temperature was recorded to monitor safety and physiological response. Measurements were taken via tympanic thermometer at baseline (0 hours) and at 2, 3, 4, 5, 6, 7 and 24 hours (±2 hours) following the administration of each AGN-CognI.Q dose.
Outcome measures
| Measure |
AGN-CognI.Q 800 mg
n=12 Participants
Participants receiving 800 mg (4 capsules) under fasting conditions.
|
AGN-CognI.Q 1200 mg
n=10 Participants
Participants receiving 1200 mg (6 capsules) under fasting conditions.
|
AGN-CognI.Q 1600 mg
n=10 Participants
Participants receiving 1600 mg (8 capsules) under fasting conditions.
|
AGN-CognI.Q 2000 mg
n=5 Participants
Participants receiving 2000 mg (10 capsules) under fasting conditions.
|
|---|---|---|---|---|
|
Body Temperature Measurements From Baseline Through 24 Hours Post-dose
Pre-dose
|
36.06 Degrees Celsius (°C)
Standard Deviation 0.57
|
36.06 Degrees Celsius (°C)
Standard Deviation 0.43
|
36.03 Degrees Celsius (°C)
Standard Deviation 0.55
|
35.62 Degrees Celsius (°C)
Standard Deviation 0.41
|
|
Body Temperature Measurements From Baseline Through 24 Hours Post-dose
2 h Post-dose
|
36.04 Degrees Celsius (°C)
Standard Deviation 0.46
|
35.68 Degrees Celsius (°C)
Standard Deviation 0.37
|
35.98 Degrees Celsius (°C)
Standard Deviation 0.80
|
35.76 Degrees Celsius (°C)
Standard Deviation 0.50
|
|
Body Temperature Measurements From Baseline Through 24 Hours Post-dose
3 h Post-dose
|
35.82 Degrees Celsius (°C)
Standard Deviation 0.39
|
35.75 Degrees Celsius (°C)
Standard Deviation 0.30
|
36.03 Degrees Celsius (°C)
Standard Deviation 0.55
|
35.78 Degrees Celsius (°C)
Standard Deviation 0.33
|
|
Body Temperature Measurements From Baseline Through 24 Hours Post-dose
4 h Post-dose
|
35.90 Degrees Celsius (°C)
Standard Deviation 0.42
|
35.64 Degrees Celsius (°C)
Standard Deviation 0.49
|
35.97 Degrees Celsius (°C)
Standard Deviation 0.56
|
35.78 Degrees Celsius (°C)
Standard Deviation 0.26
|
|
Body Temperature Measurements From Baseline Through 24 Hours Post-dose
5 h Post-dose
|
36.02 Degrees Celsius (°C)
Standard Deviation 0.35
|
35.91 Degrees Celsius (°C)
Standard Deviation 0.36
|
36 Degrees Celsius (°C)
Standard Deviation 0.61
|
36.08 Degrees Celsius (°C)
Standard Deviation 0.60
|
|
Body Temperature Measurements From Baseline Through 24 Hours Post-dose
6 h Post-dose
|
36.06 Degrees Celsius (°C)
Standard Deviation 0.45
|
35.78 Degrees Celsius (°C)
Standard Deviation 0.32
|
36.13 Degrees Celsius (°C)
Standard Deviation 0.64
|
36.02 Degrees Celsius (°C)
Standard Deviation 0.40
|
|
Body Temperature Measurements From Baseline Through 24 Hours Post-dose
7 h Post-dose
|
35.94 Degrees Celsius (°C)
Standard Deviation 0.49
|
35.84 Degrees Celsius (°C)
Standard Deviation 0.34
|
35.91 Degrees Celsius (°C)
Standard Deviation 0.69
|
36.10 Degrees Celsius (°C)
Standard Deviation 0.47
|
|
Body Temperature Measurements From Baseline Through 24 Hours Post-dose
24 h Post-dose
|
35.72 Degrees Celsius (°C)
Standard Deviation 0.26
|
35.83 Degrees Celsius (°C)
Standard Deviation 0.66
|
35.99 Degrees Celsius (°C)
Standard Deviation 0.61
|
35.82 Degrees Celsius (°C)
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: From first dose of study drug to 4 weeks (± 7 days) following the last dose.Population: This was a single-arm sequential dose-escalation study in which participants received escalating single doses of AGN-CognI.Q (800, 1200, 1600, and 2000 mg). Adverse events were summarized across dose levels because the same participants could contribute data at multiple doses. The safety population included all participants who received at least one study dose.
Evaluation of clinical safety and toxicity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
AGN-CognI.Q 800 mg
n=12 Participants
Participants receiving 800 mg (4 capsules) under fasting conditions.
|
AGN-CognI.Q 1200 mg
n=10 Participants
Participants receiving 1200 mg (6 capsules) under fasting conditions.
|
AGN-CognI.Q 1600 mg
n=5 Participants
Participants receiving 1600 mg (8 capsules) under fasting conditions.
|
AGN-CognI.Q 2000 mg
n=10 Participants
Participants receiving 2000 mg (10 capsules) under fasting conditions.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
AGN-Cogni.Q 800 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
AGN-CognI.Q 1200 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
AGN-CognI.Q 1600 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
AGN-CognI.Q 2000 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AGN-Cogni.Q 800 mg
n=12 participants at risk
Participants receiving 800 mg (4 capsules) under fasting conditions.
|
AGN-CognI.Q 1200 mg
n=10 participants at risk
Participants receiving 1200 mg (6 capsules) under fasting conditions.
|
AGN-CognI.Q 1600 mg
n=10 participants at risk
Participants receiving 1600 mg (8 capsules) under fasting conditions.
|
AGN-CognI.Q 2000 mg
n=5 participants at risk
Participants receiving 2000 mg (10 capsules) under fasting conditions.
|
|---|---|---|---|---|
|
Social circumstances
Euphoria
|
0.00%
0/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
10.0%
1/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
20.0%
1/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
10.0%
1/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
|
Blood and lymphatic system disorders
INR Increased
|
8.3%
1/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
|
Blood and lymphatic system disorders
Activated PTT Prolonged
|
8.3%
1/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
20.0%
1/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
10.0%
1/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
10.0%
1/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
10.0%
1/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
|
Investigations
Dizziness
|
0.00%
0/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
20.0%
1/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
|
General disorders
Increased Libido
|
0.00%
0/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
10.0%
1/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
|
Cardiac disorders
Non-specific T Wave Abnormality
|
0.00%
0/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
20.0%
1/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
10.0%
1/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
|
Psychiatric disorders
Restless
|
8.3%
1/12 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/10 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
0.00%
0/5 • Adverse events were monitored from the first dose of the study drug until 4 weeks (± 7 days) following the final dose for each participant.
Adverse events were graded using CTCAE v5.0. Both related and unrelated events are included. Events were identified through systematic assessments including laboratory tests, ECGs, and physical examinations. This was a sequential dose-escalation study in which participants could receive multiple dose levels; therefore adverse events are summarized across doses rather than reported separately by dose.
|
Additional Information
Junxuan Lu, PhD, Bernard B. Brodie Professor of Pharmacology
Pennsylvania State University
Phone: 7175318964
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place