Trial Outcomes & Findings for A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism (NCT NCT02369796)
NCT ID: NCT02369796
Last Updated: 2017-03-31
Results Overview
Area under the pharmacodynamic (PD) total serum testosterone (ST) concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose
Results posted on
2017-03-31
Participant Flow
Participants took part in the study at 1 investigative site in the United Kingdom from 10 February 2015 to 3 November 2015.
Overweight/obese male participants with a diagnosis of hypogonadotropic hypogonadism were enrolled in 1 of 5 treatment groups: once weekly TAK-448 3 µg, 1 µg or 0.3 µg or twice weekly TAK-448 0.3 µg or 0.1 µg.
Participant milestones
| Measure |
TAK-448 3 µg Once Weekly
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Twice Weekly
TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
|
TAK-448 0.1 µg Twice Weekly
TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2a Pharmacodynamic Study of TAK-448 in Participants With Hypogonadotropic Hypogonadism
Baseline characteristics by cohort
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=3 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
n=3 Participants
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Twice Weekly
n=3 Participants
TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
|
TAK-448 0.1 µg Twice Weekly
n=3 Participants
TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 8.02 • n=99 Participants
|
50.7 years
STANDARD_DEVIATION 4.62 • n=107 Participants
|
51.7 years
STANDARD_DEVIATION 3.79 • n=206 Participants
|
56.0 years
STANDARD_DEVIATION 3.61 • n=7 Participants
|
45.0 years
STANDARD_DEVIATION 19.16 • n=31 Participants
|
50.8 years
STANDARD_DEVIATION 9.04 • n=30 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
2 participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
3 participants
n=31 Participants
|
13 participants
n=30 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
3 participants
n=31 Participants
|
15 participants
n=30 Participants
|
|
Height
|
168 cm
STANDARD_DEVIATION 7 • n=99 Participants
|
174 cm
STANDARD_DEVIATION 6 • n=107 Participants
|
181 cm
STANDARD_DEVIATION 18 • n=206 Participants
|
178 cm
STANDARD_DEVIATION 6 • n=7 Participants
|
178 cm
STANDARD_DEVIATION 12 • n=31 Participants
|
176 cm
STANDARD_DEVIATION 10 • n=30 Participants
|
|
Weight
|
104 kg
STANDARD_DEVIATION 30 • n=99 Participants
|
113 kg
STANDARD_DEVIATION 10 • n=107 Participants
|
119 kg
STANDARD_DEVIATION 26 • n=206 Participants
|
115 kg
STANDARD_DEVIATION 7 • n=7 Participants
|
110 kg
STANDARD_DEVIATION 26 • n=31 Participants
|
112 kg
STANDARD_DEVIATION 19 • n=30 Participants
|
|
Body Mass Index
|
36 kg/m^2
STANDARD_DEVIATION 8 • n=99 Participants
|
37 kg/m^2
STANDARD_DEVIATION 1 • n=107 Participants
|
36 kg/m^2
STANDARD_DEVIATION 2 • n=206 Participants
|
36 kg/m^2
STANDARD_DEVIATION 2 • n=7 Participants
|
34 kg/m^2
STANDARD_DEVIATION 4 • n=31 Participants
|
36 kg/m^2
STANDARD_DEVIATION 4 • n=30 Participants
|
|
Smoking Classification
Has never smoked
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
1 participants
n=31 Participants
|
5 participants
n=30 Participants
|
|
Smoking Classification
Is current smoker
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
|
Smoking Classification
Is an ex-smoker
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
2 participants
n=31 Participants
|
9 participants
n=30 Participants
|
|
Alcohol Classification
Has never drunk
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
|
Alcohol Classification
Is current drinker
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
2 participants
n=31 Participants
|
10 participants
n=30 Participants
|
|
Alcohol Classification
Is an ex-drinker
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
1 participants
n=31 Participants
|
4 participants
n=30 Participants
|
|
Caffeine Consumption
Yes
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
2 participants
n=7 Participants
|
3 participants
n=31 Participants
|
14 participants
n=30 Participants
|
|
Caffeine Consumption
No
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dosePopulation: PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Area under the pharmacodynamic (PD) total serum testosterone (ST) concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Outcome measures
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=3 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
n=3 Participants
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
|---|---|---|---|
|
Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Once Weekly Dosing Groups
|
1.9 percent change
Standard Deviation 11.3
|
13.5 percent change
Standard Deviation 24.9
|
14.9 percent change
Standard Deviation 16.3
|
PRIMARY outcome
Timeframe: Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dosePopulation: PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Area under the PD total ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Outcome measures
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=3 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
|---|---|---|---|
|
Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Twice Weekly Dosing Groups
|
-2.8 percent change
Standard Deviation 3.7
|
6.0 percent change
Standard Deviation 12.3
|
—
|
PRIMARY outcome
Timeframe: Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dosePopulation: PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Outcome measures
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=3 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
n=3 Participants
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
|---|---|---|---|
|
Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Once Weekly Dosing Groups
|
3.55 percent change
Standard Deviation 9.08
|
11.1 percent change
Standard Deviation 28.0
|
7.92 percent change
Standard Deviation 8.88
|
PRIMARY outcome
Timeframe: Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dosePopulation: PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.
Outcome measures
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=3 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
|---|---|---|---|
|
Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Twice Weekly Dosing Groups
|
-9.00 percent change
Standard Deviation 4.23
|
20.5 percent change
Standard Deviation 5.33
|
—
|
PRIMARY outcome
Timeframe: Day 22 pre-dosePopulation: PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Outcome measures
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=3 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
n=3 Participants
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
|---|---|---|---|
|
Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Once Weekly Dosing Groups
|
5.4 nmol/L
Standard Deviation 1.3
|
4.4 nmol/L
Standard Deviation 3.1
|
8.7 nmol/L
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Day 25 pre-dosePopulation: PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Outcome measures
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=3 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
|---|---|---|---|
|
Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Twice Weekly Dosing Group
|
4.7 nmol/L
Standard Deviation 2.8
|
6.9 nmol/L
Standard Deviation 2.1
|
—
|
PRIMARY outcome
Timeframe: Day 22 pre-dosePopulation: PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure. Number of participants analyzed is number of participants evaluated for this outcome measure.
Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Outcome measures
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=3 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
n=2 Participants
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
|---|---|---|---|
|
Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Once Weekly Dosing Groups
|
0.16 nmol/L
Standard Deviation 0.03
|
0.12 nmol/L
Standard Deviation 0.07
|
0.21 nmol/L
Standard Deviation 0.004
|
PRIMARY outcome
Timeframe: Day 25 pre-dosePopulation: PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.
Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.
Outcome measures
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=3 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
|---|---|---|---|
|
Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Twice Weekly Dosing Groups
|
0.12 nmol/L
Standard Deviation 0.09
|
0.20 nmol/L
Standard Deviation 0.06
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dosePopulation: Pharmacokinetic (PK) set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=3 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
n=1 Participants
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
|---|---|---|---|
|
Cmax: Mean Maximum Observed Plasma Concentration for TAK-448 Free Base Form (TAK-448F)
Day 1
|
39.50 pg/mL
Standard Deviation 4.943
|
10.46 pg/mL
Standard Deviation 1.484
|
NA pg/mL
Standard Deviation NA
Data was not estimable as plasma concentration was below the lower level of quantification (LLOQ).
|
|
Cmax: Mean Maximum Observed Plasma Concentration for TAK-448 Free Base Form (TAK-448F)
Day 22
|
40.10 pg/mL
Standard Deviation 6.344
|
12.27 pg/mL
Standard Deviation 3.618
|
NA pg/mL
Standard Deviation NA
Data was not estimable as plasma concentration was below LLOQ.
|
SECONDARY outcome
Timeframe: Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dosePopulation: PK set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F. Here, 'n' is the participants who were analyzed at specific time point.
AUC(0-∞) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Outcome measures
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=1 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
n=1 Participants
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
|---|---|---|---|
|
AUC(0-∞): Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-448F
Day 1 (n=3, 0 1)
|
112.00 pg*hr/mL
Standard Deviation 5.686
|
NA pg*hr/mL
Standard Deviation NA
No participant was analyzed at this time point.
|
NA pg*hr/mL
Standard Deviation NA
Data was not estimable as plasma concentration was below LLOQ.
|
|
AUC(0-∞): Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-448F
Day 22 (n=3, 1, 1)
|
122.33 pg*hr/mL
Standard Deviation 10.477
|
33.30 pg*hr/mL
Standard Deviation NA
Only 1 participant was analyzed at this time point.
|
NA pg*hr/mL
Standard Deviation NA
Data was not estimable as plasma concentration was below LLOQ.
|
SECONDARY outcome
Timeframe: Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dosePopulation: PK set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F.
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Outcome measures
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=3 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
n=1 Participants
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
|---|---|---|---|
|
AUC(0-tlqc): Mean Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-448F
Day 1
|
92.23 pg*hr/mL
Standard Deviation 6.732
|
19.00 pg*hr/mL
Standard Deviation 3.470
|
NA pg*hr/mL
Standard Deviation NA
Data was not estimable as plasma concentration was below LLOQ.
|
|
AUC(0-tlqc): Mean Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-448F
Day 22
|
95.20 pg*hr/mL
Standard Deviation 11.914
|
18.37 pg*hr/mL
Standard Deviation 3.069
|
NA pg*hr/mL
Standard Deviation NA
Data was not estimable as plasma concentration was below LLOQ.
|
SECONDARY outcome
Timeframe: Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dosePopulation: Pharmacokinetic (PK) set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F. Here, 'n' is the participants who were analyzed at specific time point.
Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Outcome measures
| Measure |
TAK-448 3 µg Once Weekly
n=3 Participants
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=1 Participants
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
n=1 Participants
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
|---|---|---|---|
|
Mean Terminal Phase Elimination Half-life (T1/2) for TAK-448F
Day 22 (n=3, 1, 1)
|
2.073 hr
Standard Deviation 0.1920
|
1.150 hr
Standard Deviation NA
Only 1 participant was analyzed at this time point.
|
NA hr
Standard Deviation NA
Data was not estimable as plasma concentration was below LLOQ.
|
|
Mean Terminal Phase Elimination Half-life (T1/2) for TAK-448F
Day 1 (n=3, 0, 1)
|
1.800 hr
Standard Deviation 0.0751
|
NA hr
Standard Deviation NA
No participant was analyzed at this time point.
|
NA hr
Standard Deviation NA
Data was not estimable as plasma concentration was below LLOQ.
|
Adverse Events
TAK-448 3 µg Once Weekly
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TAK-448 1 µg Once Weekly
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TAK-448 0.3 µg Once Weekly
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TAK-448 0.3 µg Twice Weekly
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
TAK-448 0.1 µg Twice Weekly
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-448 3 µg Once Weekly
n=3 participants at risk
TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 1 µg Once Weekly
n=3 participants at risk
TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Once Weekly
n=3 participants at risk
TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
|
TAK-448 0.3 µg Twice Weekly
n=3 participants at risk
TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
|
TAK-448 0.1 µg Twice Weekly
n=3 participants at risk
TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
33.3%
1/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
66.7%
2/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
1/3 • Day 1 up to Day 39
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER