CompletedPhase 1

A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women

United States24 participantsStarted 2022-09-19

Plain-language summary

The purpose of this trial is to assess the potential for cytochrome P450 (CYP)-mediated drug-drug interactions (DDIs) with OPC-167832. The study is conducted in 2 parts: Part 1 assesses the potential effect of the CYP3A inhibitor itraconazole on the metabolism of OPC-167832 and Part 2 assesses the potential effect of the CYP3A inducer carbamazepine on the metabolism of OPC-167832 in healthy adult participants.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive.
✓. In good health at screening as determined by:
✓. Medical history
✓. Physical examination
✓. ECG
✓. Serum/urine chemistry, hematology, and serology tests
✓. 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

✕. 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 participants at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
✕. History of drug and/or alcohol abuse (as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for moderate to severe alcohol/substance use disorder) within 2 years prior to the screening visit.
✕. History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen, hepatitis C antibodies, and/or human immunodeficiency virus antibodies.
✕. History of any clinically significant drug allergy or known or suspected hypersensitivity, to any component of the IMP including structurally related drugs (eg, tricyclic antidepressants), hereditary fructose intolerance (Part 1 only), or any of the excipients.

What they're measuring

Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832

Timeframe: Up to Day 26

Part 2: Cmax of OPC-167832

Timeframe: Up to Day 32

Part 1: Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at time t (AUCt) of OPC-167832

Timeframe: Up to Day 26

Part 2: AUCt of OPC-167832

Timeframe: Up to Day 32

Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of OPC-167832

Timeframe: Up to Day 26

Part 2: AUCinfinity of OPC-167832

Timeframe: Up to Day 32

Trial details

NCT IDNCT07542847

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-18

View on ClinicalTrials.gov More Healthy Volunteers trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive.
✓. In good health at screening as determined by:
✓. Medical history
✓. Physical examination
✓. ECG
✓. Serum/urine chemistry, hematology, and serology tests
✓. 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

✕. 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 participants at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug.
✕. History of drug and/or alcohol abuse (as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for moderate to severe alcohol/substance use disorder) within 2 years prior to the screening visit.
✕. History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen, hepatitis C antibodies, and/or human immunodeficiency virus antibodies.
✕. History of any clinically significant drug allergy or known or suspected hypersensitivity, to any component of the IMP including structurally related drugs (eg, tricyclic antidepressants), hereditary fructose intolerance (Part 1 only), or any of the excipients.

What they're measuring

Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832

Timeframe: Up to Day 26

Part 2: Cmax of OPC-167832

Timeframe: Up to Day 32

Part 1: Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at time t (AUCt) of OPC-167832

Timeframe: Up to Day 26

Part 2: AUCt of OPC-167832

Timeframe: Up to Day 32

Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of OPC-167832

Timeframe: Up to Day 26

Part 2: AUCinfinity of OPC-167832

Timeframe: Up to Day 32