Clinical trial · Interventional
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
A Phase 1, Open-Label Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric pH Modification on the Pharmacokinetics of MLN1117 in Healthy Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm, Advanced or Metastatic | Neoplasm | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lansoprazole | Drug | — | UNRESOLVED |
| TAK-117 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Part 1: TAK-117 9*100 mg + TAK-117 3*300 mg
- description
- 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.
- interventionNames
- Drug: TAK-117
- type
- EXPERIMENTAL
- label
- Part 1: TAK-117 3*300 mg + TAK-117 9*100 mg
- description
- 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.
- interventionNames
- Drug: TAK-117
- type
- EXPERIMENTAL
- label
- Part 2: TAK-117 Fasted + TAK-117 Fed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Is aged 18 to 45 years inclusive, at the time of consent. 2. Is healthy adult male or female. 3. 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. 4. Suitable venous access for the study-required blood sampling, including PK sampling. 5. Has provided the voluntary written consent. Exclusion Criteria: 1. Any clinically significant abnormality at screening or medical history of cardiac, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 2. 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. 3. 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. 4. Known intolerance to TAK-117 or lansoprazole, or any of the excipients of either drug. 5. 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. 6. Has Lactose intolerance (only for Part 2).
References
Publications (0)
Data not yet available