Healthy Volunteers
Conditions
Keywords
Phenylketonuria, Drug-Drug Interaction (DDI) study
Brief summary
The purpose of this study is to assess the drug-drug interaction (DDI) of repinatrabit with ethinyl estradiol/norethindrone or norethisterone (EE/NE), metformin, rosuvastatin, carbamazepine, and methotrexate in healthy participants.
Interventions
DRUGRepinatrabit
Oral tablet.
DRUGEE/NE
Oral tablet.
DRUGMetformin
Oral tablet.
DRUGRosuvastatin
Oral tablet.
DRUGMethotrexate
Oral tablet.
DRUGCarbamazepine
Oral tablet.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Body mass index (BMI) from 18 to 35 kilograms per square meter (kg/m\^2) (inclusive). 2. Male and female (of non-childbearing potential) assigned at birth, inclusive of all gender identities. Arm 1 will only recruit biological females. 3. In good health as determined by: 1. Medical history 2. Physical examination 3. ECG 4. Serum chemistry, urinalysis, hematology, and serology tests 4. Willing to stay in the clinic for the required period and willing to be contacted for the safety follow-up via telephone contact. 5. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
Exclusion criteria
1. Female participants of childbearing potential. 2. Female participants who have used HRT within 60 days or hormonal contraceptives within 14 days prior to Day 1 (Arm 1 only). 3. Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. This includes, but is not limited to, history of or concurrent cardiac, hepatic, renal, neurologic, endocrine, gastrointestinal, respiratory, hematologic, and immunologic disease or cholecystectomy. 4. For Arm 3, participants who test positive for HLA haplotypes associated with carbamazepine-induced hypersensitivity (HLA-B\*15:02, HLA-A\*31:01, and HLA-B\*15:11). Note: Other protocol-specified Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Arms: Maximum Plasma Concentration (Cmax) | Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9 | Cmax will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure |
| All Arms: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Observable Concentration at Time t (AUCt) | Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9 | AUCt will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure. |
| All Arms: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinfinity) | Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9 | AUCinfinity will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Arms: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Arm 1: up to Day 25; Arm 2: up to Day 16; Arm 3: up to Day 22; Arm 4: up to Day 15 | — |
| All Arms: Number of Participants With Potentially Clinically Relevant Changes in 12-Lead Electrocardiogram (ECG) Tests | Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9 | — |
| All Arms: Number of Participants With Potentially Clinically Relevant Changes in Vital Signs | Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9 | — |
| All Arms: Number of Participants With Potentially Clinically Relevant Changes in Clinical Laboratory Tests | Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9 | — |
| All Arms: Time to Maximum (Peak) Plasma Concentration (Tmax) | Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9 | Tmax will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure. |
| All Arms: Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F) | Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9 | CL/F will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure. |
| All Arms: Volume of Distribution Following Extravascular Administration (Vz/F) | Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9 | Vz/F will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure. |
| All Arms: Terminal Phase Elimination Half-Life (t1/2,z) | Arm 1: up to Day 19; Arm 2: up to Day 10, Arm 3: up to Day 13; Arm 4: up to Day 6 | The t1/2,z will be assessed for EE/NE in Arm 1, metformin and rosuvastatin in Arm 2, repinatrabit in Arm 3, and methotrexate in Arm 4 in this outcome measure. |
Countries
Australia
Contacts
CONTACTOtsuka Call Center
Outcome results
None listed