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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Repinatrabit + EE/NE | Experimental | Participants will first receive a single dose of EE/NE, orally, followed by repinatrabit in combination with EE/NE or alone, up to Day 18. |
|
| Arm 2: Repinatrabit + (Metformin + Rosuvastatin) | Experimental | Participants will receive a single dose of metformin and rosuvastatin, orally, followed by repinatrabit in combination with metformin and rosuvastatin or alone, up to Day 9. |
|
| Arm 3: Repinatrabit + Carbamazepine | Experimental | Participants will receive a single dose of repinatrabit, orally, followed by carbamazepine in combination with repinatrabit or alone, up to Day 15. |
|
| Arm 4: Repinatrabit + Methotrexate | Experimental | Participants will receive a single dose of methotrexate, orally, followed by repinatrabit in combination with methotrexate or alone, up to Day 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repinatrabit | Drug | Oral tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| All Arms: Maximum Plasma Concentration (Cmax) | 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 | 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: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Observable Concentration at Time t (AUCt) | 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. | 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: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinfinity) | 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. | Arm 1: up to Day 19; Arm 2: up to Day 10; Arm 3: up to Day 16; Arm 4: up to Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Body mass index (BMI) from 18 to 35 kilograms per square meter (kg/m^2) (inclusive).
Male and female (of non-childbearing potential) assigned at birth, inclusive of all gender identities. Arm 1 will only recruit biological females.
In good health as determined by:
Willing to stay in the clinic for the required period and willing to be contacted for the safety follow-up via telephone contact.
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:
Note: Other protocol-specified Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Otsuka Call Center | Contact | 844-687-8522 | Otsuka-ProfessionalServices@otsuka-us.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Recruiting | Melbourne | Victoria | 3004 | Australia |
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| Label | URL |
|---|---|
| Otsuka Clinical Trials website | View source |
| Otsuka Clinical Trial Transparency | View source |
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Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
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|
| EE/NE | Drug | Oral tablet. |
|
| Metformin | Drug | Oral tablet. |
|
| Rosuvastatin | Drug | Oral tablet. |
|
| Methotrexate | Drug | Oral tablet. |
|
| Carbamazepine | Drug | Oral tablet. |
|
| 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) | 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. | 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: Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F) | 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. | 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: Volume of Distribution Following Extravascular Administration (Vz/F) | 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. | 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: Terminal Phase Elimination Half-Life (t1/2,z) | 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. | Arm 1: up to Day 19; Arm 2: up to Day 10, Arm 3: up to Day 13; Arm 4: up to Day 6 |
| ID | Term |
|---|---|
| D010661 | Phenylketonurias |
| ID | Term |
|---|---|
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000068718 | Rosuvastatin Calcium |
| D008727 | Methotrexate |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
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