Trial Outcomes & Findings for Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants (NCT NCT04454918)
NCT ID: NCT04454918
Last Updated: 2022-03-07
Results Overview
Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability for plasma TAK-906, calculated as geometric least squares mean ratio: \[Actual Dose (IV) x AUC∞ (oral)\] / \[Actual Dose (oral) x AUC∞ (IV)\] multiplied (x) 100, where AUC∞ for IV infusion was normalized to a 50 mg dose.
COMPLETED
PHASE1
6 participants
Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1
2022-03-07
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 30 July 2020 to 29 September 2020.
Healthy male participants were enrolled in this study to receive TAK-906 capsule followed by radio-labelled TAK-906 intravenous (IV) infusion on Day 1 of Treatment Period 1 and radio-labelled TAK-906 oral solution on Day 1 of Treatment Period 2. There was a 7-day Washout Period between the two periods.
Participant milestones
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg + [14C]-TAK-906 50 mg
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 micrograms (μg) \[approximately 1 microcurie (μCi)\], IV infusion, once on Day 1 of Treatment Period 1, followed by a Washout Period of 7 days, further followed by \[14C\]-TAK-906 50 mg (approximately 100 μCi), solution, orally, once on Day 1 of Treatment Period 2.
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|---|---|
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Treatment Period 1 (Day 1)
STARTED
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6
|
|
Treatment Period 1 (Day 1)
COMPLETED
|
6
|
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Treatment Period 1 (Day 1)
NOT COMPLETED
|
0
|
|
Washout Period (Day 2 to 8)
STARTED
|
6
|
|
Washout Period (Day 2 to 8)
COMPLETED
|
6
|
|
Washout Period (Day 2 to 8)
NOT COMPLETED
|
0
|
|
Treatment Period 2(Day9[Day1of Period2])
STARTED
|
6
|
|
Treatment Period 2(Day9[Day1of Period2])
COMPLETED
|
6
|
|
Treatment Period 2(Day9[Day1of Period2])
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]-TAK-906 in Healthy Male Participants
Baseline characteristics by cohort
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg + [14C]-TAK-906 50 mg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg (approximately 1 μCi), IV infusion, once on Day 1 of Treatment Period 1, followed by a Washout Period of 7 days, further followed by \[14C\]-TAK-906 50 mg (approximately 100 μCi), solution, orally, once on Day 1 of Treatment Period 2.
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|---|---|
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Age, Continuous
|
36.7 years
STANDARD_DEVIATION 8.04 • n=5 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=5 Participants
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|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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|
Region of Enrollment
United States
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6 Participants
n=5 Participants
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Weight
|
87.30 kg
STANDARD_DEVIATION 13.242 • n=5 Participants
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Height
|
181.7 cm
STANDARD_DEVIATION 8.19 • n=5 Participants
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|
Body Mass Index (BMI)
|
26.408 kg/m^2
STANDARD_DEVIATION 2.9179 • n=5 Participants
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PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1Population: Pharmacokinetic (PK) Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-906 50 mg capsules followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion in Period 1 were evaluated for this outcome measure.
Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability for plasma TAK-906, calculated as geometric least squares mean ratio: \[Actual Dose (IV) x AUC∞ (oral)\] / \[Actual Dose (oral) x AUC∞ (IV)\] multiplied (x) 100, where AUC∞ for IV infusion was normalized to a 50 mg dose.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
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|---|---|
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Period 1: Absolute Bioavailability Based on Ratio of Dose Normalized Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞ ) for TAK-906
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9.12 percent absolute bioavailability
Interval 7.49 to 11.1
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PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
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|---|---|
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Period 2: Cum%Dose (UR): Cumulative Percentage of Total Radioactivity Excreted in Urine for [14C]-TAK-906
|
2.162 percentage of dose
Geometric Coefficient of Variation 21.8
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PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
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|---|---|
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Period 2: Cum%Dose (FE): Cumulative Percentage of Total Radioactivity Excreted in Feces for [14C]-TAK-906
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94.44 percentage of dose
Geometric Coefficient of Variation 1.9
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PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
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|---|---|
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Period 2: Combined Cum%Dose: Cumulative Combined Percent of Total Radioactivity Excreted in Urine and Feces for [14C]-TAK-906
|
96.65 percentage of dose
Geometric Coefficient of Variation 1.7
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SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
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|---|---|
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Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-906 and Metabolite (M23) After Oral Administration
TAK-906
|
29.72 ng/mL
Geometric Coefficient of Variation 49.2
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|
Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-906 and Metabolite (M23) After Oral Administration
Metabolite (M23)
|
2.293 ng/mL
Geometric Coefficient of Variation 50.4
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
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|---|---|
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Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration
TAK-906
|
1.750 hour (hr)
Interval 1.0 to 4.0
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|
Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration
Metabolite (M23)
|
1.750 hour (hr)
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
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|---|---|
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Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration
TAK-906
|
78.62 ng*hr/mL
Geometric Coefficient of Variation 24.5
|
|
Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration
Metabolite (M23)
|
6.185 ng*hr/mL
Geometric Coefficient of Variation 37.3
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure. Number analyzed is the number of participants with data available for analysis for the specified category.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
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|---|---|
|
Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration
TAK-906
|
0.6598 percentage of AUC
Geometric Coefficient of Variation 58.5
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|
Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration
Metabolite (M23)
|
4.288 percentage of AUC
Geometric Coefficient of Variation 67.7
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure. Number analyzed is the number of participants with data available for analysis for the specified category.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
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|---|---|
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Period 1: t(1/2)z : Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration
TAK-906
|
3.892 hours (hr)
Geometric Coefficient of Variation 73.1
|
|
Period 1: t(1/2)z : Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration
Metabolite (M23)
|
1.722 hours (hr)
Geometric Coefficient of Variation 24.1
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
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|---|---|
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Period 1: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase for TAK-906 After Oral Administration
|
3545 Liters
Geometric Coefficient of Variation 78.3
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the oral dose of TAK-906 50 mg capsules in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
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|---|---|
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Period 1: CL/F: Apparent Total Plasma Clearance for TAK-906 After Oral Administration
|
631.3 L/hr
Geometric Coefficient of Variation 24.2
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
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|---|---|
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Period 1: Ceoi: Plasma Total Radioactivity Concentration at the End of Infusion for [14C]-TAK-906
|
3.529 nanogramequivalents/milliliter(ng eq/mL)
Geometric Coefficient of Variation 18.5
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 1: AUClast: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906
|
2.047 ng eq*hr/mL
Geometric Coefficient of Variation 14.3
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=3 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 1: AUC∞: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906
|
1.976 ng eq*hr/mL
Geometric Coefficient of Variation 14.2
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=3 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 1: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Total Radioactivity Concentration for [14C]-TAK-906
|
10.847 hr
Geometric Coefficient of Variation 137.1
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]-TAK-906
|
3795 picograms (pg)/mL
Geometric Coefficient of Variation 14.1
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 1: CL: Total Clearance for [14C]-TAK-906
|
57.55 L/hr
Geometric Coefficient of Variation 11.8
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 1: Vss: Volume of Distribution During the Terminal Disposition Phase for [14C]-TAK-906
|
33.04 Liters
Geometric Coefficient of Variation 14.2
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906
|
1549 pg*hr/mL
Geometric Coefficient of Variation 10.7
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 1: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for [14C]-TAK-906
|
0.3908 percentage of AUC
Geometric Coefficient of Variation 42.6
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the \[14C\]-TAK-906 μg IV infusion in Treatment Period 1 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 1: t(1/2)z: Terminal Disposition Phase Half-life for [14C]-TAK-906
|
1.196 hr
Geometric Coefficient of Variation 21.2
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: Cmax: Maximum Observed Plasma Concentration for TAK-906 and M23 After Oral Administration
TAK-906
|
26.81 ng/mL
Geometric Coefficient of Variation 31.1
|
|
Period 2: Cmax: Maximum Observed Plasma Concentration for TAK-906 and M23 After Oral Administration
Metabolite (M23)
|
1.086 ng/mL
Geometric Coefficient of Variation 48.1
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration
TAK-906
|
0.500 hr
Interval 0.5 to 1.5
|
|
Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and M23 After Oral Administration
Metabolite (M23)
|
0.999 hr
Interval 0.5 to 1.5
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration
TAK-906
|
46.54 ng*hr/mL
Geometric Coefficient of Variation 23.5
|
|
Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 and M23 After Oral Administration
Metabolite (M23)
|
2.111 ng*hr/mL
Geometric Coefficient of Variation 47.7
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Number analyzed is the number of participants with data available for analysis for the given category.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and M23 After Oral Administration
TAK-906
|
49.40 ng*hr/mL
Geometric Coefficient of Variation 18.6
|
|
Period 2: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and M23 After Oral Administration
Metabolite (M23)
|
2.490 ng*hr/mL
Geometric Coefficient of Variation 50.1
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Number analyzed is the number of participants with data available for analysis for the given category.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration
Metabolite (M23)
|
8.013 percentage of AUC
Geometric Coefficient of Variation 50.0
|
|
Period 2: AUC%Extrap: Percent of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC∞) Extrapolated for TAK-906 and M23 After Oral Administration
TAK-906
|
3.993 percentage of AUC
Geometric Coefficient of Variation 96.7
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Number analyzed is the number of participants with data available for analysis for the given category.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: t(1/2)z: Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration
TAK-906
|
9.993 hr
Geometric Coefficient of Variation 29.4
|
|
Period 2: t(1/2)z: Terminal Disposition Phase Half-life for TAK-906 and M23 After Oral Administration
Metabolite (M23)
|
1.833 hr
Geometric Coefficient of Variation 57.9
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase for TAK-906 After Oral Administration
|
14430 Liters
Geometric Coefficient of Variation 29.7
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: CL/F: Apparent Total Plasma Clearance for TAK-906 After Oral Administration
|
1007 L/hr
Geometric Coefficient of Variation 18.6
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: Cmax: Maximum Observed Plasma Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
|
39.85 ng eq/mL
Geometric Coefficient of Variation 33.6
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: Tmax: Time to Reach the Maximum Plasma Total Radioactivity Concentration (Cmax) for [14C]-TAK-906 After Oral Administration
|
0.758 hr
Interval 0.51 to 1.51
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: AUCt: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Time of the Last Common Time Point t for [14C]-TAK-906 After Oral Administration
|
109.0 ng eq*hr/mL
Geometric Coefficient of Variation 25.6
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: AUClast: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 After Oral Administration
|
135.5 ng eq*hr/mL
Geometric Coefficient of Variation 20.2
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=5 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: AUC∞: Area Under the Plasma Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 After Oral Administration
|
144.3 ng eq*hr/mL
Geometric Coefficient of Variation 19.0
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=5 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
|
35.539 hr
Geometric Coefficient of Variation 26.2
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: Cmax: Maximum Observed Whole Blood Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
|
28.41 ng eq/mL
Geometric Coefficient of Variation 26.7
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: Tmax: Time to Reach the Maximum Whole Blood Total Radioactivity Concentration (Cmax) for [14C]-TAK-906 After Oral Administration
|
0.504 hr
Interval 0.5 to 1.5
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: AUClast: Area Under the Whole Blood Total Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-TAK-906 After Oral Administration
|
83.17 ng eq*hr/mL
Geometric Coefficient of Variation 13.1
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=5 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: AUC∞: Area Under the Whole Blood Total Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-906 After Oral Administration
|
87.25 ng eq*hr/mL
Geometric Coefficient of Variation 13.8
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Treatment Period 2Population: PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (e.g., exposure to treatment, availability of measurements and absence of major protocol violations). Participants who received the dose of \[14C\]-TAK-906 50 mg oral solution in Treatment Period 2 were evaluated for this outcome measure. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=5 Participants
TAK-906 50 mg, capsule, orally, once on Day 1, followed by \[14C\]-TAK-906 100 μg \[approximately 1 μCi\], IV infusion, once on Day 1 of Treatment Period 1.
|
|---|---|
|
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Total Radioactivity Concentration for [14C]-TAK-906 After Oral Administration
|
16.964 hr
Geometric Coefficient of Variation 112.1
|
Adverse Events
TAK-906 50 mg + [14C]-TAK-906 100 μg
[14C]-TAK-906 50 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-906 50 mg + [14C]-TAK-906 100 μg
n=6 participants at risk
TAK-906 50 mg, capsule, orally, followed by \[14C\]-TAK-906 100 μg (approximately 1 μCi), infusion, intravenously, once on Day 1 of Treatment Period 1.
|
[14C]-TAK-906 50 mg
n=6 participants at risk
\[14C\]-TAK-906 50 mg (approximately 100 μCi), solution, orally, once on Day 1 of Treatment Period 2.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From first dose of study drug up to 30 ± 2 days after last dose of the study drug (Up to approximately 41 days)
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. Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for adverse events was collected and reported for Treatment Period 1 and Treatment Period 2.
|
16.7%
1/6 • From first dose of study drug up to 30 ± 2 days after last dose of the study drug (Up to approximately 41 days)
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. Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for adverse events was collected and reported for Treatment Period 1 and Treatment Period 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first dose of study drug up to 30 ± 2 days after last dose of the study drug (Up to approximately 41 days)
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. Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for adverse events was collected and reported for Treatment Period 1 and Treatment Period 2.
|
16.7%
1/6 • From first dose of study drug up to 30 ± 2 days after last dose of the study drug (Up to approximately 41 days)
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. Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for adverse events was collected and reported for Treatment Period 1 and Treatment Period 2.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first dose of study drug up to 30 ± 2 days after last dose of the study drug (Up to approximately 41 days)
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. Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for adverse events was collected and reported for Treatment Period 1 and Treatment Period 2.
|
16.7%
1/6 • From first dose of study drug up to 30 ± 2 days after last dose of the study drug (Up to approximately 41 days)
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. Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for adverse events was collected and reported for Treatment Period 1 and Treatment Period 2.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • From first dose of study drug up to 30 ± 2 days after last dose of the study drug (Up to approximately 41 days)
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. Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for adverse events was collected and reported for Treatment Period 1 and Treatment Period 2.
|
16.7%
1/6 • From first dose of study drug up to 30 ± 2 days after last dose of the study drug (Up to approximately 41 days)
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. Safety Population included all participants who received at least one dose of the study drug. As prespecified in the protocol data for adverse events was collected and reported for Treatment Period 1 and Treatment Period 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER