Trial Outcomes & Findings for A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants (NCT NCT04234672)

NCT ID: NCT04234672

Last Updated: 2021-06-30

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, calculated for plasma TAK-831 as \[Actual Dose (IV) x AUCinf (oral)\] / \[Actual Dose (oral) x AUCinf (IV)\] x 100.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 6 participants
• Primary outcome timeframe: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1
• Results posted on: 2021-06-30

Participant Flow

Participants took part in the study at 1 investigative site in the United States from 17 Feb 2020 to 04 April 2020.

Healthy male participants were enrolled in this study to receive TAK-831 tablets followed by radio-labelled TAK-831 intravenous (IV) infusion on Day 1 of Treatment Period 1 and radio-labelled TAK-831 oral suspension on Day 1 of Treatment Period 2. There was an 8-day washout period between the two periods.

Participant milestones

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg TAK-831 5 X 100 mg tablets, orally, once on Day 1, followed by \[14C\]TAK-831 50 micrograms (μg) \[approximately 1 microcurie (μCi)\], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2.
Treatment Period 1 (Day 1) STARTED	6
Treatment Period 1 (Day 1) COMPLETED	6
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

A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants

Baseline characteristics by cohort

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg + [14C]TAK-831 500 mg n=6 Participants TAK-831 5 X 100 mg tablets, orally, once on Day 1, followed by \[14C\]TAK-831 50 micrograms (μg) \[approximately 1 microcurie (μCi)\], infusion, intravenously (IV), once on Day 1 of Treatment Period 1, followed by a washout period of 8 days, further followed by \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, once under fasted state on Day 1 of Treatment Period 2.
Age, Continuous	46.2 years STANDARD_DEVIATION 6.9 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	6 Participants n=93 Participants
Height	174.8 cm STANDARD_DEVIATION 6.1 • n=93 Participants
Weight	80.25 kg STANDARD_DEVIATION 6.5 • n=93 Participants
Body Mass Index (BMI)	26.28 kg/m^2 STANDARD_DEVIATION 1.6 • n=93 Participants

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets and 50 ug IV dose in Treatment 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, calculated for plasma TAK-831 as [Actual Dose (IV) x AUCinf (oral)] / [Actual Dose (oral) x AUCinf (IV)] x 100.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 1: Percent Absolute Bioavailability (%F) for TAK-831	17.34 percent absolute bioavailability Geometric Coefficient of Variation 31.3	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: Total Radioactivity Expressed as Cumulative Percentage of Dose of [14C]TAK-831 Eliminated in Urine and Feces Combined [Combined Cum%Dose]	88.66 percentage of dose Geometric Coefficient of Variation 3.6	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: Total Radioactivity Expressed as Cumulative Amount of [14C]TAK-831 Eliminated in Urine and Feces Combined (Combined CumAe)	472.7 mg equivalents (eq) of parent drug Geometric Coefficient of Variation 3.3	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Urine (Cum%Dose [UR])	27.50 percentage of dose Geometric Coefficient of Variation 19.8	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: Percentage of Administered Radioactive Dose of [14C]TAK-831 Excreted in Feces (Cum%Dose [Fe])	60.71 percentage of dose Geometric Coefficient of Variation 5.9	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: Cmax: Maximum Observed Plasma Concentration of TAK-831	1243 ng/mL Geometric Coefficient of Variation 33.2	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-831	0.799 hours (hr) Interval 0.52 to 1.05	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of TAK-831 in Plasma	10.314 hr Standard Deviation 6.3900	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-831	4198 ng*hr/mL Geometric Coefficient of Variation 30.8	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-831	4171 ng*hr/mL Geometric Coefficient of Variation 30.8	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: Cmax: Maximum Observed Plasma Radioactivity Concentration	5878 ng eq/mL Geometric Coefficient of Variation 11.4	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: Tmax: Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax)	2.005 hr Interval 1.01 to 4.17	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Plasma Radioactivity Concentration	3.162 hr Standard Deviation 0.3068	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: AUCinf: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity	31010 ng eq*hr/mL Geometric Coefficient of Variation 9.8	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: AUClast: Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration	28860 ng eq*hr/mL Geometric Coefficient of Variation 8.8	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: Cmax: Maximum Observed Whole Blood Radioactivity Concentration	2881 ng eq/g Geometric Coefficient of Variation 9.2	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: Tmax: Time to Reach the Maximum Whole Blood Radioactivity Concentration (Cmax)	2.001 hr Interval 2.0 to 4.15	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: t(1/2)z: Terminal Disposition Phase Half-life of Whole Blood Radioactivity Concentration	2.580 hr Standard Deviation 0.3922	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: AUCinf: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity	15180 ng eq*hr/g Geometric Coefficient of Variation 13.7	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose in Treatment Period 2

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: AUClast: Area Under the Whole Blood Radioactivity Concentration-time Curve From Time 0 to Last Quantifiable Concentration	13420 ng eq*hr/g Geometric Coefficient of Variation 14.2	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of \[14C\]TAK-831 500 mg oral suspension in Treatment Period 2 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 2: CLR: Renal Clearance for TAK-831 in Urine	0.06547 L/hr Geometric Coefficient of Variation 38.6	—	—

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the \[14C\]TAK-831 50 μg IV infusion in Period 1 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 1: Ceoi: Plasma Concentration at the End of Infusion for [14C]TAK-831	2903 picograms per milliliter (pg/mL) Geometric Coefficient of Variation 26.7	—	—

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 1: Cmax: Maximum Observed Plasma Concentration for TAK-831 After Oral Administration	1121 ng/mL Geometric Coefficient of Variation 45.5	—	—

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831 After Oral Administration	1.255 hr Interval 0.5 to 2.1	—	—

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 After Oral Administration	3436 nanogram hour/milliliter (ng*hr/mL) Geometric Coefficient of Variation 45.7	—	—

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the \[14C\]TAK-831 50 ug IV dose in Treatment Period 1 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]TAK-831 After IV Administration	1992 pg*hr/mL Geometric Coefficient of Variation 18.1	—	—

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 96.5 hours) post-dose in Treatment Period 1

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets in Treatment Period 1 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-831 After Oral Administration	3397 ng*hr/mL Geometric Coefficient of Variation 46.6	—	—

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 95 hours) post-dose in Treatment Period 1

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the \[14C\]TAK-831 50 ug IV dose in Treatment Period 1 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]TAK-831 After IV Administration	1972 pg*hr/mL Geometric Coefficient of Variation 18.1	—	—

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 96.5 hours for TAK-831 and up to 95 hours for [14C]TAK-831) post-dose

Population: PK-evaluable population included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Participants who received the oral dose of TAK-831 5 X 100 mg tablets and \[14C\]TAK-831 50 ug IV dose in Treatment Period 1 were evaluated for this outcome measure.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg n=6 Participants \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Period 1: t(1/2)z: Terminal Disposition Half-life for TAK-831 After Oral and [14C]TAK-831 After IV Administration in Plasma	12.278 hr Standard Deviation 6.0291	3.815 hr Standard Deviation 1.0456	—

SECONDARY outcome

Timeframe: From first dose of study drug up to 30 days after last dose of study drug (up to approximately 38 days)

Population: Safety Population included all participants who received at least one dose of the study drug. Data is reported as per the treatment received in Treatment Periods 1 and 2.

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg n=6 Participants \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg n=6 Participants \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Day 14

Population: Safety Population included all participants who received at least one dose of the study drug and will be included in the safety evaluations. Data is reported as per the treatment received in Treatment Periods 1 and 2.

The ECG parameters were considered TEAEs if they were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal physiologic fluctuation).

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg n=6 Participants \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg n=6 Participants \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Number of Participants With TEAEs Related to Electrocardiogram (ECG)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 14

Population: Safety Population included all participants who received at least one dose of the study drug and will be included in the safety evaluations. Data is reported as per the treatment received in Treatment Periods 1 and 2.

Vital Signs included body temperature, respiratory rate, blood pressure, and heart rate. Any clinically significant changes from Baseline as assessed by the investigator were reported as TEAEs.

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg n=6 Participants \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg n=6 Participants \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Number of Participants With TEAEs Related to Vital Signs	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 14

Population: Safety Population included all participants who received at least one dose of the study drug and will be included in the safety evaluations. Data is reported as per the treatment received in Treatment Periods 1 and 2.

The laboratory parameters included parameters of hematology, serum checmistry and urinalysis. The laboratory parameters were considered TEAEs if their values were judged to be clinically significant (i.e., if some action or intervention was required or if the Investigator judged the change to be beyond the range of normal).

Outcome measures

Measure	TAK-831 500 mg + [14C]TAK-831 50 μg n=6 Participants TAK-831 5 X 100 mg tablets, orally, followed by \[14C\]TAK-831 50 μg (approximately 1 μCi), 15-minute IV infusion, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg n=6 Participants \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg n=6 Participants \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Number of Participants With TEAEs Related to Laboratory Parameters	0 Participants	0 Participants	0 Participants

Adverse Events

TAK-831 500 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

[14C]TAK-831 50 μg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

[14C]TAK-831 500 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TAK-831 500 mg n=6 participants at risk TAK-831 5 X 100 mg tablets, orally, once on Day 1 of Treatment Period 1.	[14C]TAK-831 50 μg n=6 participants at risk \[14C\]TAK-831 50 μg (approximately 1 μCi), infusion, 15-minute IV infusion, once on Day 1 of Treatment Period 1 after the TAK-831 oral dose, followed by a washout period of at least 7 days.	[14C]TAK-831 500 mg n=6 participants at risk \[14C\]TAK-831 500 mg (approximately 100 μCi), suspension, orally, under fasted state, once on Day 1 of Treatment Period 2.
Eye disorders Eye irritation	0.00% 0/6 • From first dose of study drug up to 30 days after last dose of the study drug (up to approximately 38 days) Data is reported as per the treatment received in Periods 1 and 2.	0.00% 0/6 • From first dose of study drug up to 30 days after last dose of the study drug (up to approximately 38 days) Data is reported as per the treatment received in Periods 1 and 2.	16.7% 1/6 • From first dose of study drug up to 30 days after last dose of the study drug (up to approximately 38 days) Data is reported as per the treatment received in Periods 1 and 2.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/6 • From first dose of study drug up to 30 days after last dose of the study drug (up to approximately 38 days) Data is reported as per the treatment received in Periods 1 and 2.	0.00% 0/6 • From first dose of study drug up to 30 days after last dose of the study drug (up to approximately 38 days) Data is reported as per the treatment received in Periods 1 and 2.	16.7% 1/6 • From first dose of study drug up to 30 days after last dose of the study drug (up to approximately 38 days) Data is reported as per the treatment received in Periods 1 and 2.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • From first dose of study drug up to 30 days after last dose of the study drug (up to approximately 38 days) Data is reported as per the treatment received in Periods 1 and 2.	0.00% 0/6 • From first dose of study drug up to 30 days after last dose of the study drug (up to approximately 38 days) Data is reported as per the treatment received in Periods 1 and 2.	16.7% 1/6 • From first dose of study drug up to 30 days after last dose of the study drug (up to approximately 38 days) Data is reported as per the treatment received in Periods 1 and 2.

Additional Information

Neurocrine Medical Information

Neurocrine Biosciences

Phone: 877-641-3461

Email: medinfo@neurocrine.com

Results disclosure agreements

• Principal investigator is a sponsor employee Generally, the PI may publish results of the study following the publication of results by the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER