A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants

NCT03482453 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: TAK-788-1001U1111-1208-9582
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative to a reference (Process A) DiC of TAK-788 in healthy participants.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (14)

• Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

  Baseline up to 30 days after the last dose of study drug (Day 31)

• Part 1: Number of Participants With One or More Serious Adverse Events (SAEs)

  Baseline up to 30 days after the last dose of study drug (Day 31)

• Part 1: Number of Participants With Clinically Significant Abnormal Laboratory Values

  Baseline up to 30 days after the last dose of study drug (Day 31)

• Part 1: Number of Participants With Clinically Significant Abnormal Vital Signs

  Baseline up to 30 days after the last dose of study drug (Day 31)

• Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-788

  Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

• Part 3, Cmax: Maximum Observed Plasma Concentration for TAK-788

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

• Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788

  Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

• Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788

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

• Part 2, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788

  Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

• Part 3, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788

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

• Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788

  Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

• Part 3, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788

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

• Part 2, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788

  Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

• Part 3, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788

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

Secondary Outcomes (9)

• Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-788 and Its Active Metabolites AP32960 and AP32914

  Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

• Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 and Its Active Metabolites AP32960 and AP32914

  Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

• Part 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 and Its Active Metabolites, AP32960 and AP32914

  Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

• Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and Its Active Metabolites AP32960 and AP32914

  Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

• Part 1, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 and Its Active Metabolites AP32960 and AP32914

  Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Study Arms (9)

Part 1 Cohort 1: TAK-788

EXPERIMENTAL

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1.

Drug: TAK-788; Drug: Placebo

Part 1 Cohort 2: TAK-788

EXPERIMENTAL

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 1.

Drug: TAK-788; Drug: Placebo

Part 1 Cohort 3: TAK-788

EXPERIMENTAL

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 2.

Drug: TAK-788; Drug: Placebo

Part 1 Cohort 4: TAK-788

EXPERIMENTAL

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 3.

Drug: TAK-788; Drug: Placebo

Part 1 Cohort 5: TAK-788

EXPERIMENTAL

TAK-788, capsule, orally or TAK-788 matching placebo capsule, orally, once under fasted conditions on Day 1 following review of safety data from Cohort 4.

Drug: TAK-788; Drug: Placebo

Part 2: TAK-788 Fed + TAK-788 Fasted

EXPERIMENTAL

TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fed conditions with low-fat meal (Treatment A), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fasted conditions (Treatment B). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1.

Drug: TAK-788

Part 2: TAK-788 Fasted + TAK-788 Fed

EXPERIMENTAL

TAK-788, capsule, orally, once on Day 1 of Intervention Period 1 under fasted conditions (Treatment B), followed by at least 7 days washout period, further followed by TAK-788, capsule, orally, once on Day 1 of Intervention Period 2 under fed conditions with low-fat meal (Treatment A). TAK-788 dose will be determined based on review of safety and tolerability data from cohorts of Part 1.

Drug: TAK-788

Part 3: TAK-788 DiC (reference) + TAK-788 DiC (test)

EXPERIMENTAL

TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC B (test), orally, under fasted condition, once on Day 1 of Intervention Period 2.

Drug: TAK-788

Part 3: TAK-788 DiC (test) + TAK-788 DiC (reference)

EXPERIMENTAL

TAK-788 160 mg, DiC B (test), orally, under fasted condition, once, on Day 1 of Intervention Period 1, followed by at least 7 days washout period, further followed by TAK-788 160 mg, DiC A (reference), orally, under fasted condition, once on Day 1 of Intervention Period 2.

Drug: TAK-788

Interventions

TAK-788 DRUG

TAK-788 capsules.

Also known as: AP32788

Part 1 Cohort 1: TAK-788; Part 1 Cohort 2: TAK-788; Part 1 Cohort 3: TAK-788; Part 1 Cohort 4: TAK-788; Part 1 Cohort 5: TAK-788; Part 2: TAK-788 Fasted + TAK-788 Fed; Part 2: TAK-788 Fed + TAK-788 Fasted

Placebo DRUG

TAK-788 placebo-matching capsules.

Part 1 Cohort 1: TAK-788; Part 1 Cohort 2: TAK-788; Part 1 Cohort 3: TAK-788; Part 1 Cohort 4: TAK-788; Part 1 Cohort 5: TAK-788

Eligibility Criteria

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

You may qualify if:

• Body weight of greater than or equal to (\>=) 45 kilogram (kg) (women) or \>=55 kg (men) and a body mass index of 18.0 to 30.0 kilogram per square meter (kg/m\^2) at screening.
• Nonsmoker (never smoked or greater than \[\>\] 20 years from last occurrence of smoking).
• Normal organ function including hepatic, renal, and bone marrow function.

You may not qualify if:

• Manifestations of malabsorption due to prior gastro-intestinal (GI) surgery, GI disease, or for an unknown other reason that may alter the PK of TAK-788.
• Pulmonary infection ongoing or within 30 days of informed consent.
• Inability to undergo venipuncture and/or tolerate venous access.
• Inability to tolerate multiple blood sampling.
• Ongoing or active infection, including but not limited to, the requirement for intravenous (IV) antibiotics.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (1)

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

mobocertinib

Results Point of Contact

• Title: Medical director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 29, 2018
• Study Start: March 28, 2018
• Primary Completion: December 22, 2018
• Study Completion: January 18, 2019
• Last Updated: January 29, 2020
• Results First Posted: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)