Trial Outcomes & Findings for TAK-385 Phase I Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability Study (NCT NCT02252354)
NCT ID: NCT02252354
Last Updated: 2016-10-27
Results Overview
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to no more than (NMT) 4.7 millibecquerel (MBq) (127 microcurie \[mCi\]). Cmax was calculated as disintegration per minute per mL (DPM/mL). Total \[14C\]-TAK-385 determination of plasma and whole blood samples was determined by accelerator mass spectrometry (AMS) method.
COMPLETED
PHASE1
12 participants
Day 1 pre-dose and various time-points (up to 288 hours) post-dose
2016-10-27
Participant Flow
Participants took part in the study at 1 investigative site in United Kingdom from 29 September 2014 to 27 October 2014.
Healthy cohort of male participants were enrolled in this 2 part study, in 1 of 2 treatment groups as follows : Part 1: \[14C\]-TAK-385 80 milligram (mg); Part 2:TAK-385 80 mg + \[14C\]-TAK-385 80 microgram (mcg)
Participant milestones
| Measure |
Part 1: [14C]-TAK-385
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
Part 2: TAK-385 + [14C]-TAK-385
TAK-385 80 mg, tablets, orally, and \[14C\]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TAK-385 Phase I Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability Study
Baseline characteristics by cohort
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
Part 2: TAK-385 + [14C]-TAK-385 IV
n=6 Participants
TAK-385 80 mg, tablets, orally, and \[14C\]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Greater than(>)17 to less than equal to(<=)64
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Caffeine Consumption
Yes
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Caffeine Consumption
No
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Xanthine Consumption
Yes
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Xanthine Consumption
No
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Smoking Classification
Never smoked
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Smoking Classification
Current smoker
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Smoking Classification
Ex-smoker
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Alcohol Classification
The participant has never drunk
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Alcohol Classification
The participant is a current drinker
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Alcohol Classification
The participant is an ex-drinker
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 288 hours) post-dosePopulation: Pharmacokinetic (PK) set included all participants in the safety set with at least one measurable plasma concentration.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to no more than (NMT) 4.7 millibecquerel (MBq) (127 microcurie \[mCi\]). Cmax was calculated as disintegration per minute per mL (DPM/mL). Total \[14C\]-TAK-385 determination of plasma and whole blood samples was determined by accelerator mass spectrometry (AMS) method.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385
Whole Blood Radioactivity
|
2.0 hours
Full Range 1.4354 • Interval 0.2 to 4.0
|
|
Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385
Plasma Radioactivity
|
2.0 hours
Full Range 1.4354 • Interval 0.2 to 4.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product (\[14C\]-TAK-385).
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385
|
1.2 hours
Full Range 1.4748 • Interval 0.2 to 4.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 288 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). Cmax was measured in nanogram equivalent per milliliter (ng eq/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total \[14C\]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385
Whole Blood Radioactivity
|
45.6 ng eq/mL
Standard Deviation 24.2
|
|
Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385
Plasma Radioactivity
|
56.1 ng eq/mL
Standard Deviation 34.2
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product (\[14C\]-TAK-385).
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-385
|
44.7 nanogram per milliliter (ng/mL)
Standard Deviation 29.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 288 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
AUC(0-inf) is measure of area under the curve from time 0 to infinity. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). AUC(0-inf) was measured in nanogram equivalent\*hour per milliliter (ng eq\*hr/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total \[14C\]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: AUC(0-inf): Area Under the Plasma and Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385
Plasma Radioactivity
|
1771.4 ng eq*hr/mL
Standard Deviation 476.5
|
|
Part 1: AUC(0-inf): Area Under the Plasma and Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385
Whole Blood Radioactivity
|
1521.5 ng eq*hr/mL
Standard Deviation 421.2
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
AUC(0-inf) is area under the concentration-time curve from time 0 to infinity. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product (\[14C\]-TAK-385) .
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
|
382.2 nanogram hour per milliliter (ng*hr/mL)
Standard Deviation 128.2
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 288 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-168\]). Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total \[14C\]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: AUC(0-168): Area Under the Plasma and Whole Blood Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385
Plasma Radioactivity
|
982.7 ng eq*hr/mL
Standard Deviation 288.7
|
|
Part 1: AUC(0-168): Area Under the Plasma and Whole Blood Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385
Whole Blood Radioactivity
|
756.5 ng eq*hr/mL
Standard Deviation 229.5
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
AUC(0-168) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau\]), where tau is the length of the dosing interval -168 hours in this study). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product (\[14C\]-TAK-385).
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385
|
357.5 ng*hr/mL
Standard Deviation 119.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 288 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total \[14C\]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385
Whole Blood Radioactivity
|
285.3 hours
Standard Deviation 32.9 • Interval 255.9 to 333.7
|
|
Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385
Plasma Radioactivity
|
226.1 hours
Standard Deviation 22.0 • Interval 192.4 to 246.1
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product (\[14C\]-TAK-385).
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385
|
60.7 hours
Standard Deviation 6.6 • Interval 53.6 to 69.3
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to Day 288) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. Total \[14-C\] determination of urine and feces samples were determined by Liquid Scintillation Counting (LSC).
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces
Feces
|
82.7 percent recovery of radioactivity
Standard Deviation 6.3
|
|
Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces
Urine
|
4.3 percent recovery of radioactivity
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to NMT 37.0 kilobecquerel (kBq) (1000 nanocurie \[nCi\]). Total radioactivity and \[14C\]-TAK-385 determination of plasma samples was determined by AMS.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: Tmax : Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) for [14C]-TAK-385
|
0.2 hours
Full Range 0.0455 • Interval 0.1 to 0.2
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: Tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385
|
2.2 hours
Full Range 2.0897 • Interval 0.5 to 6.0
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and \[14C\]-TAK-385 determination of plasma samples was determined by AMS.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for [14C]-TAK-385
|
2.6 ng eq/mL
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
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 |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for TAK-385
|
24.6 ng/mL
Standard Deviation 13.2
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various sampling time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
AUC(0-inf) is measure of area under the curve from time 0 to Infinity. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).AUC(0-inf) was corrected according to Hamilton Pool result.Total radioactivity and \[14C\]-TAK-385 determination of plasma samples was determined by AMS.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: AUC(0-inf): Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385
|
4.2 ng eq*hr/mL
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 288 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
AUC(0-inf) is measure of area under the curve from time 0 to Infinity.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
|
225.2 ng*hr/mL
Standard Deviation 110.8
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
AUC(0-168) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval :168 hours in this study (AUC(0-tau\]). AUC(0-168) was corrected according to Hamilton Pool result.Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and \[14C\]-TAK-385 determination of plasma samples was determined by AMS.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: AUC(0-168): Area Under the Plasma Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385
|
3.2 ng eq*hr/mL
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-tau\]). AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385
|
214.5 ng*hr/mL
Standard Deviation 106.3
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and \[14C\]-TAK-385 determination of plasma samples was determined by AMS.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma Radioactivity for [14C]-TAK-385
|
110.5 hours
Standard Deviation 16.2 • Interval 96.0 to 134.5
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385
|
50.6 hours
Standard Deviation 6.0 • Interval 42.5 to 60.3
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Absolute bioavailability, defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: Absolute Bioavailability for the Oral Tablet Formulation
|
11.6 percentage bioavailability
Standard Deviation 7.2
|
PRIMARY outcome
Timeframe: 0 to 191 hours post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Amount of total \[14\]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total \[14\]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity
Metabolite-A
|
0.3 percentage of recovered radioactivity
Standard Deviation 0.4
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity
Metabolite-B
|
NA percentage of recovered radioactivity
Standard Deviation NA
Data were not reported because none of the values were above lower limit of detection.
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity
Others
|
44.0 percentage of recovered radioactivity
Standard Deviation 8.1
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity
Total 14[C]
|
100 percentage of recovered radioactivity
Standard Deviation 0.0
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity
TAK-385
|
5.1 percentage of recovered radioactivity
Standard Deviation 3.2
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity
Metabolite-C
|
50.6 percentage of recovered radioactivity
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: 0 to 144 hours post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Amount of total \[14\]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total \[14\]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity
Total 14[C]
|
100 percentage of recovered radioactivity
Standard Deviation 0.0
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity
Metabolite-B
|
NA percentage of recovered radioactivity
Standard Deviation NA
Data were not reported because none of the values were above lower limit of detection.
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity
Metabolite-C
|
NA percentage of recovered radioactivity
Standard Deviation NA
Data were not reported because none of the values were above lower limit of detection.
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity
Others
|
47.4 percentage of recovered radioactivity
Standard Deviation 19.0
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity
TAK-385
|
52.6 percentage of recovered radioactivity
Standard Deviation 19.0
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity
Metabolite-A
|
NA percentage of recovered radioactivity
Standard Deviation NA
Data were not reported because none of the values were above lower limit of detection.
|
PRIMARY outcome
Timeframe: 0 to 191 hours post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Amount of total \[14\]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total \[14\]C.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose
Total 14[C]
|
80.6 percentage of dose
Standard Deviation 5.7
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose
TAK-385
|
4.2 percentage of dose
Standard Deviation 2.9
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose
Metabolite-A
|
0.3 percentage of dose
Standard Deviation 0.3
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose
Metabolite-C
|
40.6 percentage of dose
Standard Deviation 4.9
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose
Others
|
35.6 percentage of dose
Standard Deviation 7.3
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose
Metabolite-B
|
NA percentage of dose
Standard Deviation NA
Data were not reported because none of the values were above lower limit of detection.
|
PRIMARY outcome
Timeframe: 0 to 144 hours post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Amount of total \[14\]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total \[14\]C.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose
Metabolite-A
|
NA percentage of dose
Standard Deviation NA
Data were not reported because none of the values were above lower limit of detection.
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose
Others
|
2.0 percentage of dose
Standard Deviation 0.9
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose
Total 14[C]
|
4.1 percentage of dose
Standard Deviation 0.7
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose
TAK-385
|
2.2 percentage of dose
Standard Deviation 0.9
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose
Metabolite-B
|
NA percentage of dose
Standard Deviation NA
Data were not reported because none of the values were above lower limit of detection.
|
|
Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose
Metabolite-C
|
NA percentage of dose
Standard Deviation NA
Data were not reported because none of the values were above lower limit of detection.
|
PRIMARY outcome
Timeframe: Hour 1 post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Percentage of \[14\]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose
Metabolite A and B
|
3 percentage of dose
0.7
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose
Metabolite-C
|
1.5 percentage of dose
NA
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose
TAK-385
|
55.3 percentage of dose
0.9
|
PRIMARY outcome
Timeframe: Hour 2 post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Percentage of \[14\]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose
Metabolite A and B
|
2.5 percentage of dose
0.7
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose
Metabolite-C
|
1.2 percentage of dose
NA
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose
TAK-385
|
68.2 percentage of dose
0.9
|
PRIMARY outcome
Timeframe: Hour 4 post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Percentage of \[14\]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose
Metabolite A and B
|
2.2 percentage of dose
0.7
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose
Metabolite-C
|
0.8 percentage of dose
NA
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose
TAK-385
|
58.8 percentage of dose
0.9
|
PRIMARY outcome
Timeframe: Hour 8 post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Percentage of \[14\]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose
Metabolite A and B
|
3.2 percentage of dose
0.7
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose
Metabolite-C
|
1.2 percentage of dose
NA
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose
TAK-385
|
41.5 percentage of dose
0.9
|
PRIMARY outcome
Timeframe: Hour 12 post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Percentage of \[14\]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose
Metabolite A and B
|
3.8 percentage of dose
0.7
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose
Metabolite-C
|
1.3 percentage of dose
NA
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose
TAK-385
|
45.7 percentage of dose
0.9
|
PRIMARY outcome
Timeframe: Hour 24 post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Percentage of \[14\]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose
TAK-385
|
53 percentage of dose
0.9
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose
Metabolite A and B
|
2.6 percentage of dose
0.7
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose
Metabolite-C
|
2.1 percentage of dose
NA
|
PRIMARY outcome
Timeframe: Hour 36 post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Percentage of \[14\]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose
Metabolite A and B
|
2.2 percentage of dose
0.7
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose
Metabolite-C
|
2.7 percentage of dose
NA
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose
TAK-385
|
52.4 percentage of dose
0.9
|
PRIMARY outcome
Timeframe: Hour 48 post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Percentage of \[14\]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose
Metabolite A and B
|
3.2 percentage of dose
0.7
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose
Metabolite-C
|
4.5 percentage of dose
NA
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose
TAK-385
|
48 percentage of dose
0.9
|
PRIMARY outcome
Timeframe: Hour 72 post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Percentage of \[14\]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose
Metabolite A and B
|
3.0 percentage of dose
0.7
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose
Metabolite-C
|
3.2 percentage of dose
NA
|
|
Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose
TAK-385
|
45.9 percentage of dose
0.9
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr). CL which was calculated by correcting the \[14C\]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Apparent Oral Clearance (CL/F) for TAK-385
|
218.2 L/hr
Standard Deviation 66.7
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr).CL which was calculated by correcting the \[14C\]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h).
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: Apparent Oral Clearance (CL/F) for TAK-385
|
382.9 L/hr
Standard Deviation 154.7
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 1: Volume of Distribution (Vz/F) for TAK-385
|
18878.7 Liter (L)
Standard Deviation 5114.4
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz).
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: Volume of Distribution (Vz/F) for TAK-385
|
28245.1 L
Standard Deviation 13011.8
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 72 hours) post-dose for urine; Day 1 pre-dose and various time-points (up to 48 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant.
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces
Urine
|
13.3 percent recovery of radioactivity
Standard Deviation 3.0
|
|
Part 2: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces
Feces
|
22.2 percent recovery of radioactivity
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and various time-points (up to 168 hours) post-dosePopulation: PK set included all participants in the safety set with at least one measurable plasma concentration.
CL is clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in L/hr. CL is a quantitative measure of the rate at which a drug substance is removed from the body. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).
Outcome measures
| Measure |
Part 1: [14C]-TAK-385
n=6 Participants
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
|---|---|
|
Part 2: Clearance (CL) for [14C]-TAK-385
|
29.4 L/hr
Standard Deviation 4.5
|
Adverse Events
Part 1: [14C]-TAK-385
Part 2: TAK-385 + [14C]-TAK-385 IV
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: [14C]-TAK-385
n=6 participants at risk
\[14C\]-TAK-385 80 mg, solution, orally, single dose on Day 1.
|
Part 2: TAK-385 + [14C]-TAK-385 IV
n=6 participants at risk
TAK-385 80 mg, tablets, orally, and \[14C\]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
|
|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (+/- 2) after the last dose of study drug.
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (+/- 2) after the last dose of study drug.
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
Headache
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (+/- 2) after the last dose of study drug.
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.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (+/- 2) after the last dose of study drug.
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.
|
|
Renal and urinary disorders
Micturition disorder
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (+/- 2) after the last dose of study drug.
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%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (+/- 2) after the last dose of study drug.
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 No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER