A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants

NCT02625259 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: MLN1117-1002U1111-1159-5909
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the relative bioavailability of a new tablet formulation of TAK-117 (new clinical trial material \[NTM\]) compared to the TAK-117 Process B capsules (current clinical trial material \[CTM\]) (Part 1), to assess the effects of food on the oral bioavailability and pharmacokinetics (PK) of TAK-117 (Part 2), and to assess the effects of gastric pH-modifying agent on the PK of TAK-117 in healthy participants (Part 3).

Conditions

Neoplasm, Advanced or Metastatic

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (4)

• Cmax: Maximum Observed Plasma Concentration for TAK-117

  Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117

  Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose

• AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117

  Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) 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-117

  Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose

Secondary Outcomes (1)

• Part 1: Renal Clearance (CLr) of TAK-117

  Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

Study Arms (5)

Part 1: TAK-117 9*100 mg + TAK-117 3*300 mg

EXPERIMENTAL

TAK-117900 milligram (mg), capsules, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 900 mg, tablets, orally, once on Day 15.

Drug: TAK-117

Part 1: TAK-117 3*300 mg + TAK-117 9*100 mg

EXPERIMENTAL

TAK-117 900 mg tablets, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 900 mg, capsules, orally, once on Day 15.

Drug: TAK-117

Part 2: TAK-117 Fasted + TAK-117 Fed

EXPERIMENTAL

TAK-117 at the dose determined in Part 1, tablets, in fasted condition, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 at the dose determined in Part 1, tablets, with a standard high-fat meal, orally, once on Day 15.

Drug: TAK-117

Part 2: TAK-117 Fed + TAK-117 Fasted

EXPERIMENTAL

TAK-117 at the dose determined in Part 1, tablets, with a standard high-fat meal, orally, once on Day 1, followed by 2 weeks of washout, followed by TAK-117 at the dose determined in Part 1, tablets, in fasted condition, orally, once on Day 15.

Drug: TAK-117

Part 3: TAK-117 + Lansoprazole

EXPERIMENTAL

TAK-117 at the dose determined in Part 1, tablets, orally, once on Day 1, followed by lansoprazole 30 mg, tablets or capsules, once daily from Day 10 to Day 15, followed by TAK-117 at the dose determined in Part 1, tablets, orally, once on Day 15.

Drug: Lansoprazole; Drug: TAK-117

Interventions

TAK-117 DRUG

TAK-117 capsules

Part 1: TAK-117 3*300 mg + TAK-117 9*100 mg; Part 1: TAK-117 9*100 mg + TAK-117 3*300 mg

Lansoprazole DRUG

Lansoprazole capsules

Part 3: TAK-117 + Lansoprazole

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is aged 18 to 45 years inclusive, at the time of consent.
• Is healthy adult male or female.
• Weighs greater than or equal to (\>=) 45 kilogram (kg) (female) or \>=55 kg (male), and body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m\^2), inclusive, at screening.
• Suitable venous access for the study-required blood sampling, including PK sampling.
• Has provided the voluntary written consent.

You may not qualify if:

• Any clinically significant abnormality at screening or medical history of cardiac, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• Manifestations of malabsorption due to prior GI surgery, GI disease, or for an unknown other reason that may alter the PK of TAK-117 or lansoprazole.
• Creatinine clearance less than or equal to (\<=) 90 milliliter per minute (mL/min) based either on Cockroft-Gault estimate or based on a 12- or 24-hour urine collection during screening.
• Known intolerance to TAK-117 or lansoprazole, or any of the excipients of either drug.
• A positive test result for human immunodeficiency virus (HIV), hepatitis A antibody (HAVAb), hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody Anti-HBc (IgM), or hepatitis C antibody (HCVAb) tests at screening, or serological reactions for syphilis during screening.
• Has Lactose intolerance (only for Part 2).

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

serabelisib; Lansoprazole

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 9, 2015
• Study Start: January 8, 2016
• Primary Completion: May 16, 2016
• Study Completion: July 22, 2016
• Last Updated: January 8, 2018
• Results First Posted: January 8, 2018

Record last verified: 2017-07