A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants

NCT03706469 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: TAK-831-1006U1111-1217-5483
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (3)

• AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831

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

• AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831

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

• Cmax: Maximum Observed Plasma Concentration for TAK-831

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

Secondary Outcomes (1)

• Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)

  Day 1 post dose up to 14 days after the last dose of study drug (Up to Day 47)

Study Arms (4)

Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg)

EXPERIMENTAL

TAK-831 T2 50 milligram (mg), tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods.

Drug: TAK-831 T2; Drug: TAK-831 T3

Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg)

EXPERIMENTAL

TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods.

Drug: TAK-831 T2; Drug: TAK-831 T3

Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg)

EXPERIMENTAL

TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods.

Drug: TAK-831 T2; Drug: TAK-831 T3

Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)

EXPERIMENTAL

TAK-831 T3 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 1, followed by TAK-831 T2 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 2, followed by TAK-831 T2 600 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 3, followed by TAK-831 T3 50 mg, tablet, orally, once, under fasted condition on Day 1 of Treatment Period 4, further followed by TAK-831 T3 600 mg, tablet, orally, once, under fed condition on Day 1 of Treatment Period 5. There will be a washout period of at least 7 days between study drug in-take in subsequent treatment periods.

Drug: TAK-831 T2; Drug: TAK-831 T3

Interventions

TAK-831 T2 DRUG

TAK-831 T2 Tablets.

Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg); Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg); Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg); Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)

TAK-831 T3 DRUG

TAK-831 T3 Tablets.

Fasted (T2 50 mg+T3 50 mg+T3 600 mg+T2 600 mg)+Fed (T3 600 mg); Fasted (T2 600 mg+T3 600 mg+T3 50 mg+T2 50 mg)+Fed (T3 600 mg); Fasted (T3 50 mg+T2 600 mg+T2 50 mg+T3 600 mg)+Fed (T3 600 mg); Fasted (T3 600 mg+T2 50 mg+T2 600 mg+T3 50 mg)+Fed (T3 600 mg)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than (\<) 30.0 kilogram per square meter (kg/m\^2), at Screening.

You may not qualify if:

• History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
• Smokes more than 20 cigarettes or equivalent per day within 3 months prior to the first dose and is unwilling to discontinue use of any tobacco- or nicotine-containing products during the confinement period(s) of the study.
• Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
• Is lactose intolerant or unable/unwilling to eat the high-fat breakfast.
• Donation of blood or significant blood loss within 56 days prior to the first dosing.

Sponsors & Collaborators

• Neurocrine Biosciences: lead
• Takeda: collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Results Point of Contact

• Title: Neurocrine Medical Information
• Organization: Neurocrine Biosciences

medinfo@neurocrine.com

877-641-3461

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: October 18, 2018
• Primary Completion: December 11, 2018
• Study Completion: December 22, 2018
• Last Updated: June 14, 2021
• Results First Posted: December 23, 2019

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)