Trial Outcomes & Findings for A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation (NCT NCT03101293)

NCT ID: NCT03101293

Last Updated: 2021-06-14

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Results posted on

2021-06-14

Participant Flow

Participants took part in the study at 1 investigative site in the United States from 04 April 2017 to 26 May 2017.

Healthy participants were enrolled in this 2-way crossover study and randomized in 1 of the 2 treatment sequences which determined the order to receive TAK-831 400 milligram (mg) film-coated tablets under fasted conditions and TAK-831 400 mg tablet under fed conditions (nutritional drink).

Participant milestones

Participant milestones
Measure	TAK-831 400 mg Fasted + TAK-831 400 mg Fed TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fed state, once on Day 1 of Intervention Period 2.	TAK-831 400 mg Fed + TAK-831 400 mg Fasted TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fasted state, once on Day 1 of Intervention Period 2.
Intervention Period 1 STARTED	7	8
Intervention Period 1 COMPLETED	7	8
Intervention Period 1 NOT COMPLETED	0	0
Washout Period (at Least 7 Days) STARTED	7	8
Washout Period (at Least 7 Days) COMPLETED	6	8
Washout Period (at Least 7 Days) NOT COMPLETED	1	0
Intervention Period 2 STARTED	6	8
Intervention Period 2 COMPLETED	6	8
Intervention Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	TAK-831 400 mg Fasted + TAK-831 400 mg Fed TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fed state, once on Day 1 of Intervention Period 2.	TAK-831 400 mg Fed + TAK-831 400 mg Fasted TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fasted state, once on Day 1 of Intervention Period 2.
Washout Period (at Least 7 Days) Positive drug urine screen	1	0

Baseline Characteristics

The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Population: The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.

Outcome measures

Outcome measures
Measure	TAK-831 400 mg Fasted n=15 Participants TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2.	TAK-831 400 mg Fed n=14 Participants TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2.
Cmax: Maximum Observed Plasma Concentration for TAK-831	650.04 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 47.7	865.48 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 53.5

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Population: The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.

Outcome measures

Outcome measures
Measure	TAK-831 400 mg Fasted n=15 Participants TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2.	TAK-831 400 mg Fed n=14 Participants TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2.
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831	2290.8 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 53.1	2535.6 hournanogram per milliliter (hng/mL) Geometric Coefficient of Variation 58.8

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Population: The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration. The PK analysis population where data at specified time points were available.

Outcome measures

Outcome measures
Measure	TAK-831 400 mg Fasted n=13 Participants TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2.	TAK-831 400 mg Fed n=10 Participants TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2.
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831	2194.8 h*ng/mL Geometric Coefficient of Variation 53.1	2465.9 h*ng/mL Geometric Coefficient of Variation 67.8

SECONDARY outcome

Timeframe: Day 1

Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	TAK-831 400 mg Fasted n=15 Participants TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2.	TAK-831 400 mg Fed n=14 Participants TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2.
Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE)	0 percentage of participants	7.1 percentage of participants

Adverse Events

TAK-831 400 mg Fasted

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TAK-831 400 mg Fed

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TAK-831 400 mg Fasted n=15 participants at risk TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of either Intervention Period 1 or Intervention Period 2.	TAK-831 400 mg Fed n=14 participants at risk TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1 or Intervention Period 2.
Infections and infestations Upper respiratory tract infection	0.00% 0/15 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug (up to Day 23) 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.	7.1% 1/14 • Number of events 1 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of study drug (up to Day 23) At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Neurocrine Medical Information

Neurocrine Biosciences

Phone: 877-641-3461

Email: [email protected]

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

Measure	TAK-831 400 mg Fasted + TAK-831 400 mg Fed n=7 Participants TAK-831 400 mg, film-coated tablets, orally, under fasted state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fed state, once on Day 1 of Intervention Period 2.	TAK-831 400 mg Fed + TAK-831 400 mg Fasted n=8 Participants TAK-831 400 mg, film-coated tablets, orally, under fed state, once on Day 1 of Intervention Period 1, followed by at least 7 days of washout period, further followed by TAK-831 400 mg, tablet, orally, under fasted state, once on Day 1 of Intervention Period 2.	Total n=15 Participants Total of all reporting groups
Age, Continuous	35.4 years STANDARD_DEVIATION 7.98 • n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	32.6 years STANDARD_DEVIATION 11.22 • n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	33.9 years STANDARD_DEVIATION 9.61 • n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Sex: Female, Male Female	1 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	2 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	3 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Sex: Female, Male Male	6 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	6 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	12 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	1 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	8 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	14 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) Asian	1 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	1 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) Black or African American	3 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	3 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	6 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) White	3 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	5 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	8 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) More than one race	0 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Region of Enrollment United States	7 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	8 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	15 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Weight	73.3 kilogram (kg) STANDARD_DEVIATION 9.65 • n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	78.6 kilogram (kg) STANDARD_DEVIATION 11.19 • n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	76.1 kilogram (kg) STANDARD_DEVIATION 10.48 • n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Height	171.3 centimeter (cm) STANDARD_DEVIATION 6.40 • n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	173.8 centimeter (cm) STANDARD_DEVIATION 7.19 • n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	172.6 centimeter (cm) STANDARD_DEVIATION 6.71 • n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Body Mass Index (BMI)	24.9 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.17 • n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	25.9 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.45 • n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	25.5 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.30 • n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Smoking Classification Never smoked	5 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	7 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	12 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Smoking Classification Current smoker	1 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	1 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Smoking Classification Ex-smoker	1 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	1 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	2 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Alcohol Classification Never drunk	3 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	3 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	6 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Alcohol Classification Current drinker	4 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	5 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	9 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Alcohol Classification Ex-drinker	0 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	0 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Caffeine Consumption Caffeine consumption	6 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	7 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	13 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Caffeine Consumption No caffeine consumption	1 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	1 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	2 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Xanthine Consumption Xanthine consumption	6 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	7 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	13 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Xanthine Consumption No xanthine consumption	1 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	1 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	2 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Female Reproductive Status Post-menopausal	0 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	1 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	1 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Female Reproductive Status Surgically sterile	1 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	1 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	2 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.
Female Reproductive Status Not applicable (Male)	6 Participants n=39 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	6 Participants n=41 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.	12 Participants n=35 Participants • The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.