Trial Outcomes & Findings for A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants (NCT NCT06679413)
NCT ID: NCT06679413
Last Updated: 2026-07-02
Results Overview
Cmax is the maximum observed plasma concentration of Midazolam alone and in combination with ZX008 at steady state.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Results posted on
2026-07-02
Participant Flow
The study started to enroll participants in December 2024 and concluded in June 2025.
The Participant Flow refers to the Safety Set.
Participant milestones
| Measure |
3-probe Drug Cocktail Alone (Treatment Period 1)
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on D (Day) 1 during the Treatment Period 1.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period)
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 6 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|---|
|
Treatment Period 1: Days 1 - 5
STARTED
|
22
|
0
|
|
Treatment Period 1: Days 1 - 5
COMPLETED
|
22
|
0
|
|
Treatment Period 1: Days 1 - 5
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2: Days 6 - 26
STARTED
|
0
|
22
|
|
Treatment Period 2: Days 6 - 26
COMPLETED
|
0
|
22
|
|
Treatment Period 2: Days 6 - 26
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants
Baseline characteristics by cohort
| Measure |
All Treated Participants
n=22 Participants
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 1 during the Treatment Period 1. Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 mg), BID, from Day 6 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 8.5 • n=20 Participants
|
|
Age, Customized
18 - <65 years
|
22 Participants
n=20 Participants
|
|
Age, Customized
65 - <85 years
|
0 Participants
n=20 Participants
|
|
Age, Customized
>= 85 years
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
13 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
13 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours PostdosePopulation: Pharmacokinetic set (PKS) consisted of all study participants who received at least 1 dose of any of the study treatments and have at least 1 quantifiable postdose pharmacokinetic (PK) concentration measurement of the probe drugs.
Cmax is the maximum observed plasma concentration of Midazolam alone and in combination with ZX008 at steady state.
Outcome measures
| Measure |
3-probe Drug Cocktail Alone (Treatment Period 1)
n=22 Participants
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 1 during the Treatment Period 1.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2)
n=22 Participants
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 6 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2: D22-SFU)
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 22 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|---|---|
|
Maximum Concentration (Cmax) of Midazolam Alone and in Combination With ZX008 at Steady State
|
10.44 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31.6
|
8.203 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 40.6
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours PostdosePopulation: Pharmacokinetic set consisted of all study participants who received at least 1 dose of any of the study treatments and have at least 1 quantifiable postdose PK concentration measurement of the probe drugs.
Cmax is the maximum observed plasma concentration of Metformin alone and in combination with ZX008 at steady state.
Outcome measures
| Measure |
3-probe Drug Cocktail Alone (Treatment Period 1)
n=22 Participants
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 1 during the Treatment Period 1.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2)
n=22 Participants
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 6 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2: D22-SFU)
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 22 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|---|---|
|
Maximum Concentration (Cmax) of Metformin Alone and in Combination With ZX008 at Steady State
|
943.6 ng/mL
Geometric Coefficient of Variation 17.4
|
959.8 ng/mL
Geometric Coefficient of Variation 26.0
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours PostdosePopulation: Pharmacokinetic set consisted of all study participants who received at least 1 dose of any of the study treatments and have at least 1 quantifiable postdose PK concentration measurement of the probe drugs.
Cmax is the maximum observed plasma concentration of Bupropion alone and in combination with ZX008 at steady state.
Outcome measures
| Measure |
3-probe Drug Cocktail Alone (Treatment Period 1)
n=22 Participants
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 1 during the Treatment Period 1.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2)
n=22 Participants
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 6 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2: D22-SFU)
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 22 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|---|---|
|
Maximum Concentration (Cmax) of Bupropion Alone and in Combination With ZX008 at Steady State
|
76.11 ng/mL
Geometric Coefficient of Variation 39.6
|
68.50 ng/mL
Geometric Coefficient of Variation 39.1
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours PostdosePopulation: Pharmacokinetic set consisted of all study participants who received at least 1 dose of any of the study treatments and have at least 1 quantifiable postdose PK concentration measurement of the probe drugs.
AUC is area under the plasma concentration-time curve from time 0 to infinity of Midazolam alone and in combination with ZX008 at steady state.
Outcome measures
| Measure |
3-probe Drug Cocktail Alone (Treatment Period 1)
n=22 Participants
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 1 during the Treatment Period 1.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2)
n=22 Participants
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 6 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2: D22-SFU)
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 22 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|---|---|
|
Area Under the Curve From 0 to Infinity (AUC) of Midazolam Alone and in Combination With ZX008 at Steady State
|
24.84 hour*nanograms per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 46.2
|
19.08 hour*nanograms per milliliter (hr*ng/mL)
Geometric Coefficient of Variation 47.5
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours PostdosePopulation: PKS was used. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data for a few participants was excluded because of poor model fit (R\^2 less than 0.8), not enough data points to reliably estimate the drug's elimination or having a measurable drug level predose that was more than 5% of their highest concentration. All these checks were based on noncompartmental analysis.
AUC is area under the plasma concentration-time curve from time 0 to infinity of Metformin alone and in combination with ZX008 at steady state.
Outcome measures
| Measure |
3-probe Drug Cocktail Alone (Treatment Period 1)
n=19 Participants
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 1 during the Treatment Period 1.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2)
n=21 Participants
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 6 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2: D22-SFU)
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 22 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|---|---|
|
Area Under the Curve From 0 to Infinity (AUC) of Metformin Alone and in Combination With ZX008 at Steady State
|
6381 hr*ng/mL
Geometric Coefficient of Variation 22.0
|
6482 hr*ng/mL
Geometric Coefficient of Variation 23.9
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours PostdosePopulation: PKS was used. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Data for a few participants was excluded because of poor model fit (R\^2 less than 0.8), not enough data points to reliably estimate the drug's elimination or having a measurable drug level predose that was more than 5% of their highest concentration. All these checks were based on noncompartmental analysis.
AUC is area under the plasma concentration-time curve from time 0 to infinity of Bupropion alone and in combination with ZX008 at steady state.
Outcome measures
| Measure |
3-probe Drug Cocktail Alone (Treatment Period 1)
n=20 Participants
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 1 during the Treatment Period 1.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2)
n=22 Participants
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 6 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2: D22-SFU)
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 22 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|---|---|
|
Area Under the Curve From 0 to Infinity (AUC) of Bupropion Alone and in Combination With ZX008 at Steady State
|
407.7 hr*ng/mL
Geometric Coefficient of Variation 27.0
|
378.0 hr*ng/mL
Geometric Coefficient of Variation 33.0
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours PostdosePopulation: Pharmacokinetic set consisted of all study participants who received at least 1 dose of any of the study treatments and have at least 1 quantifiable postdose PK concentration measurement of the probe drugs.
AUC(0-t) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration of Midazolam alone and in combination with ZX008 at steady state.
Outcome measures
| Measure |
3-probe Drug Cocktail Alone (Treatment Period 1)
n=22 Participants
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 1 during the Treatment Period 1.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2)
n=22 Participants
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 6 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2: D22-SFU)
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 22 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|---|---|
|
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration AUC(0-t) of Midazolam Alone and in Combination With ZX008 at Steady State
|
24.09 hr*ng/mL
Geometric Coefficient of Variation 47.1
|
18.40 hr*ng/mL
Geometric Coefficient of Variation 49.0
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours PostdosePopulation: Pharmacokinetic set consisted of all study participants who received at least 1 dose of any of the study treatments and have at least 1 quantifiable postdose PK concentration measurement of the probe drugs.
AUC(0-t) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration of Metformin alone and in combination with ZX008 at steady state.
Outcome measures
| Measure |
3-probe Drug Cocktail Alone (Treatment Period 1)
n=22 Participants
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 1 during the Treatment Period 1.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2)
n=22 Participants
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 6 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2: D22-SFU)
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 22 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|---|---|
|
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration AUC(0-t) of Metformin Alone and in Combination With ZX008 at Steady State
|
6365 hr*ng/mL
Geometric Coefficient of Variation 21.4
|
6448 hr*ng/mL
Geometric Coefficient of Variation 23.3
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours PostdosePopulation: Pharmacokinetic set consisted of all study participants who received at least 1 dose of any of the study treatments and have at least 1 quantifiable postdose PK concentration measurement of the probe drugs.
AUC(0-t) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration of Bupropion alone and in combination with ZX008 at steady state.
Outcome measures
| Measure |
3-probe Drug Cocktail Alone (Treatment Period 1)
n=22 Participants
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 1 during the Treatment Period 1.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2)
n=22 Participants
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 6 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2: D22-SFU)
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 22 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|---|---|
|
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration AUC(0-t) of Bupropion Alone and in Combination With ZX008 at Steady State
|
344.8 hr*ng/mL
Geometric Coefficient of Variation 40.0
|
351.0 hr*ng/mL
Geometric Coefficient of Variation 33.6
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)Population: The Safety Set included all study participants who had received at least 1 dose of any of the study treatments.
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A treatment-emergent adverse events was defined as any AE with a start date and time on or after the first dose of any study drug or any unresolved event already present before treatment administration that worsens infrequency or intensity following exposure to any of the study drugs. The percentage of participants data was rounded to one decimal place. SFU: Safety Follow-Up.
Outcome measures
| Measure |
3-probe Drug Cocktail Alone (Treatment Period 1)
n=22 Participants
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 1 during the Treatment Period 1.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2)
n=22 Participants
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 6 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2: D22-SFU)
n=22 Participants
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 22 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
13.6 percentage of participants
|
50.0 percentage of participants
|
22.7 percentage of participants
|
Adverse Events
3-probe Drug Cocktail Alone (Treatment Period 1: D1-D5)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ZX008 15 mg BID Alone (Treatment Period 2: D6-D21)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2: D22-SFU)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3-probe Drug Cocktail Alone (Treatment Period 1: D1-D5)
n=22 participants at risk
Participants received a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on D (Day) 1 during the Treatment Period 1.
|
ZX008 15 mg BID Alone (Treatment Period 2: D6-D21)
n=22 participants at risk
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) 15 mg, bid, from Day 6 to Day 21.
|
ZX008 15 mg BID + 3-probe Drug Cocktail (Treatment Period 2: D22-SFU)
n=22 participants at risk
Participants received repeated oral doses of fenfluramine hydrochloride (ZX008) (15 milligrams \[mg\]), twice daily (BID), from Day 22 to Day 25 (morning dose only), and a single oral dose of the cocktail of 3-probe drugs (midazolam, metformin, and bupropion) on Day 22 during the Treatment Period 2.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
1/22 • Number of events 1 • From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)
A treatment-emergent adverse events was defined as any AE with a start date and time on or after the first dose of any study drug or any unresolved event already present before treatment administration that worsens infrequency or intensity following exposure to any of the study drugs. The Safety Set included all study participants who had received at least 1 dose of any of the study treatments.
|
0.00%
0/22 • From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)
A treatment-emergent adverse events was defined as any AE with a start date and time on or after the first dose of any study drug or any unresolved event already present before treatment administration that worsens infrequency or intensity following exposure to any of the study drugs. The Safety Set included all study participants who had received at least 1 dose of any of the study treatments.
|
9.1%
2/22 • Number of events 2 • From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)
A treatment-emergent adverse events was defined as any AE with a start date and time on or after the first dose of any study drug or any unresolved event already present before treatment administration that worsens infrequency or intensity following exposure to any of the study drugs. The Safety Set included all study participants who had received at least 1 dose of any of the study treatments.
|
|
General disorders
Fatigue
|
0.00%
0/22 • From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)
A treatment-emergent adverse events was defined as any AE with a start date and time on or after the first dose of any study drug or any unresolved event already present before treatment administration that worsens infrequency or intensity following exposure to any of the study drugs. The Safety Set included all study participants who had received at least 1 dose of any of the study treatments.
|
18.2%
4/22 • Number of events 4 • From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)
A treatment-emergent adverse events was defined as any AE with a start date and time on or after the first dose of any study drug or any unresolved event already present before treatment administration that worsens infrequency or intensity following exposure to any of the study drugs. The Safety Set included all study participants who had received at least 1 dose of any of the study treatments.
|
0.00%
0/22 • From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)
A treatment-emergent adverse events was defined as any AE with a start date and time on or after the first dose of any study drug or any unresolved event already present before treatment administration that worsens infrequency or intensity following exposure to any of the study drugs. The Safety Set included all study participants who had received at least 1 dose of any of the study treatments.
|
|
Nervous system disorders
Headache
|
0.00%
0/22 • From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)
A treatment-emergent adverse events was defined as any AE with a start date and time on or after the first dose of any study drug or any unresolved event already present before treatment administration that worsens infrequency or intensity following exposure to any of the study drugs. The Safety Set included all study participants who had received at least 1 dose of any of the study treatments.
|
13.6%
3/22 • Number of events 3 • From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)
A treatment-emergent adverse events was defined as any AE with a start date and time on or after the first dose of any study drug or any unresolved event already present before treatment administration that worsens infrequency or intensity following exposure to any of the study drugs. The Safety Set included all study participants who had received at least 1 dose of any of the study treatments.
|
0.00%
0/22 • From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)
A treatment-emergent adverse events was defined as any AE with a start date and time on or after the first dose of any study drug or any unresolved event already present before treatment administration that worsens infrequency or intensity following exposure to any of the study drugs. The Safety Set included all study participants who had received at least 1 dose of any of the study treatments.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60