Trial Outcomes & Findings for A Study of the Effect of Multiple Doses of Rifampin on the Single Dose Pharmacokinetics of RO5424802 (NCT NCT01940510)
NCT ID: NCT01940510
Last Updated: 2016-12-21
Results Overview
AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (\*) hour per milliliter (ng\*hour/mL).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period
Results posted on
2016-12-21
Participant Flow
Participant milestones
| Measure |
Whole Study: Alectinib + Rifampin
There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib (RO5424802) 600 milligram (mg) capsules (four 150 mg capsules) orally alone on Day 1 (Period 1), with rifampin (600 mg capsules \[two 300 mg capsules\] orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
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|---|---|
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Overall Study
STARTED
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24
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Overall Study
COMPLETED
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24
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Effect of Multiple Doses of Rifampin on the Single Dose Pharmacokinetics of RO5424802
Baseline characteristics by cohort
| Measure |
Whole Study: Alectinib + Rifampin
n=24 Participants
There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally alone on Day 1 (Period 1), with rifampin (600 mg capsules orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
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|---|---|
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Age, Continuous
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35.3 years
STANDARD_DEVIATION 9.43 • n=5 Participants
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Gender
Female
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2 Participants
n=5 Participants
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Gender
Male
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22 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: The Pharmacokinetic (PK) analysis set included all participants who received both scheduled doses of alectinib (on Day 1 and Day 17), and provided adequate PK assessments.
AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (\*) hour per milliliter (ng\*hour/mL).
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
|
Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Alectinib
|
3990 ng*hour/mL
Standard Deviation 1550
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1020 ng*hour/mL
Standard Deviation 240
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PRIMARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: PK analysis set
Cmax is the maximum observed alectinib plasma concentration, presented in nanogram per milliliter (ng/mL).
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
|
Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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Maximum Observed Plasma Concentration (Cmax) of Alectinib
|
212 ng/mL
Standard Deviation 78.3
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101 ng/mL
Standard Deviation 30.9
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SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: PK analysis set
AUC(0-inf) is the area under the RO5468924 (the major pharmacologically active metabolite of alectinib) plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the drug over time. AUC(0-inf) is presented in ng\*hour/mL.
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
|
Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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AUC(0-inf) of RO5468924
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2250 ng*hour/mL
Standard Deviation 904
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3970 ng*hour/mL
Standard Deviation 1600
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SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: PK analysis set
Cmax is the maximum observed RO5468924 (the major pharmacologically active metabolite of alectinib) plasma concentration, presented in ng/mL.
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
|
Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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Cmax of RO5468924
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90.5 ng/mL
Standard Deviation 43.7
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194 ng/mL
Standard Deviation 97.0
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SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: PK analysis set
AUC(0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-inf) is presented.
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
|
Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUC(0-inf)
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0.59 ratio
Standard Deviation 0.05
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3.96 ratio
Standard Deviation 0.67
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SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: PK analysis set
Cmax is the maximum observed plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib). The molecular weight adjusted M/P ratio (RO5468924/alectinib) for Cmax is presented.
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
|
Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for Cmax
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0.42 ratio
Standard Deviation 0.07
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1.92 ratio
Standard Deviation 0.32
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SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: PK analysis set
AUC(0-last) is the area under the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) plasma concentration time-curve from time zero to the last measured concentration. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng\*hour/mL.
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
|
Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Alectinib and RO5468924
Alectinib
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3860 ng*hour/mL
Standard Deviation 1500
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976 ng*hour/mL
Standard Deviation 234
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Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Alectinib and RO5468924
RO5468924
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2140 ng*hour/mL
Standard Deviation 876
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3850 ng*hour/mL
Standard Deviation 1570
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SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: PK analysis set
The Tmax is the time from alectinib administration to reach Cmax for alectinib and RO5468924 (the major pharmacologically active metabolite of alectinib).
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
|
Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib and RO5468924
Alectinib
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6.00 hours
Interval 4.0 to 12.0
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4.00 hours
Interval 4.0 to 8.0
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib and RO5468924
RO5468924
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8.00 hours
Interval 6.0 to 12.0
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6.00 hours
Interval 6.0 to 8.0
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SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: PK analysis set
Plasma terminal half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half. RO5468924 is the major pharmacologically active metabolite of alectinib.
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
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Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924
Alectinib
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19.2 hours
Standard Deviation 4.41
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11.0 hours
Standard Deviation 5.65
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Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924
RO5468924
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24.0 hours
Standard Deviation 3.48
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23.0 hours
Standard Deviation 11.1
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SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: PK analysis set
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
|
Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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Apparent Oral Clearance (CL/F) of Alectinib
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179 liters/hour
Standard Deviation 89.1
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627 liters/hour
Standard Deviation 170
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SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: PK analysis set
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
|
Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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Apparent Volume of Distribution (Vz/F) of Alectinib
|
4710 liters
Standard Deviation 1890
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9960 liters
Standard Deviation 5880
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SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: PK analysis set
AUC(0-inf) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the molar plasma concentration of the alectinib + RO5468924 over time. AUC(0-inf) is presented in nanomoles times (\*) hour per liter (nmol\*hour/L).
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
|
Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-inf)
|
13200 nmol*hour/L
Standard Deviation 4670
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10800 nmol*hour/L
Standard Deviation 3910
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SECONDARY outcome
Timeframe: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention periodPopulation: PK analysis set
Cmax is the maximum observed molar plasma concentration for alectinib + RO5468924 (major pharmacologically active metabolite of alectinib). Cmax is presented in nanomoles per liter (nmol/L).
Outcome measures
| Measure |
Treatment Period 1: Alectinib
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
|
Treatment Period 3: Alectinib + Rifampin
n=24 Participants
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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Total Molar Concentration of Alectinib and RO5468924 as Derived by Cmax
|
614 nmol/L
Standard Deviation 231
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594 nmol/L
Standard Deviation 251
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Adverse Events
Treatment Period 1: Alectinib
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment Period 2: Rifampin
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Treatment Period 3: Alectinib + Rifampin
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 |
Treatment Period 1: Alectinib
n=24 participants at risk
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
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Treatment Period 2: Rifampin
n=24 participants at risk
Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 8 through 16.
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Treatment Period 3: Alectinib + Rifampin
n=24 participants at risk
Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
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|---|---|---|---|
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Renal and urinary disorders
Chromaturia
|
0.00%
0/24 • Day 1 through follow-up (up to 31 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
|
58.3%
14/24 • Day 1 through follow-up (up to 31 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
|
4.2%
1/24 • Day 1 through follow-up (up to 31 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/24 • Day 1 through follow-up (up to 31 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
|
8.3%
2/24 • Day 1 through follow-up (up to 31 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
|
0.00%
0/24 • Day 1 through follow-up (up to 31 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/24 • Day 1 through follow-up (up to 31 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
|
8.3%
2/24 • Day 1 through follow-up (up to 31 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
|
0.00%
0/24 • Day 1 through follow-up (up to 31 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Day 1 through follow-up (up to 31 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
|
8.3%
2/24 • Day 1 through follow-up (up to 31 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
|
0.00%
0/24 • Day 1 through follow-up (up to 31 days)
Safety analysis set. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-emergent AE (TEAE) was defined as an AE that began or worsened in severity on or after the first dose of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER