Phase 1
Completed N=54
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
Neoplasm, Advanced or Metastatic
Source: ClinicalTrials.gov NCT02625259 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for TAK-117 — 4632.992; 6225.347; 6455.111; 7847.591 nanogram per milliliter (ng/mL)
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for TAK-117 |
4632.992; 6225.347; 6455.111; 7847.591; 5859.156; 190.172 | — |
| PRIMARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117 |
2.067; 3.000; 3.000; 6.033; 3.000; 3.517 | — |
| PRIMARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117 |
45727.280; 66015.952; 71442.968; 127143.511; 63165.064; 1018.650 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117 |
64165.340; 96293.083; 81595.634; 128336.896; 85782.122; 6547.254 | — |
| SECONDARY Part 1: Renal Clearance (CLr) of TAK-117 |
0.314; 0.311 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT02625259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.