- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02625259
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The drug being tested in this study is called TAK-117. TAK-117 is being tested to treat people who have advanced solid tumors. This study will look at the PK and relative bioavailability of new tablet formulation of TAK-117 as compare to current capsule formulation in Part 1. In Part 2 and Part 3, interaction of TAK-117 with food and a gastric pH modifying agent will be evaluated respectively in healthy participants, and will commence only after the completion of Part 1.
The study will enroll approximately 54 participants. In Part 1, participants will be randomly assigned (by chance, like flipping a coin) to 1 of the 2 crossover sequences:
- Sequence A: TAK-117 capsules (9*100 mg) first then TAK-117 tablets (3*300 mg)
- Sequence B: TAK-117 tablets (3*300 mg) first then TAK-117 capsules (9*100 mg)
Part 2 and Part 3 will be evaluated only on the new tablet formulation of TAK-117 at the dose determined in Part 1. In Part 2, participants will be randomly assigned to receive a single dose of TAK-117 in the fasted state followed by TAK-117 with standard high-fat breakfast in Sequence A or vice-versa in Sequence B. In Part 3, participants will receive a single dose of TAK-117 on Day 1 followed by lansoprazole 30 mg on Day 10 for 6 days and then second dose of TAK-117 on Day 15. Blood samples will be collected at predose and up to 72 hours postdose at prespecified time points on Days 1 and 15. Urine samples will be collected predose, 0 to 12 hours, and 12 to 24 hours postdose in Part 1 only.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 45 days. Participants will make 2 visits to the clinic in each part, during which they will remain confined to the clinic for a 4 to 10 day period for drug dosing and other study procedures. Participants will also complete a final visit 30 to 33 days after their last dose of study drug for a follow-up assessment (Day 45).
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Part 1: TAK-117 9*100 mg + TAK-117 3*300 mg
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.
|
TAK-117 capsules
TAK-117 tablets
|
Eksperimentell: Part 1: TAK-117 3*300 mg + TAK-117 9*100 mg
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.
|
TAK-117 capsules
TAK-117 tablets
|
Eksperimentell: Part 2: TAK-117 Fasted + TAK-117 Fed
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.
|
TAK-117 capsules
TAK-117 tablets
|
Eksperimentell: Part 2: TAK-117 Fed + TAK-117 Fasted
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.
|
TAK-117 capsules
TAK-117 tablets
|
Eksperimentell: Part 3: TAK-117 + Lansoprazole
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.
|
Lansoprazol kapsler
TAK-117 capsules
TAK-117 tablets
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cmax: Maximum Observed Plasma Concentration for TAK-117
Tidsramme: 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
|
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
Tidsramme: 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
|
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
Tidsramme: 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
|
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
Tidsramme: 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
|
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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Part 1: Renal Clearance (CLr) of TAK-117
Tidsramme: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
|
Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MLN1117-1002
- U1111-1159-5909 (Registeridentifikator: WHO)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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