Recruiting
Phase 1

Repinatrabit

Sponsor:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Code:

NCT07713758

Conditions

Phenylketonuria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Repinatrabit

Study Details

Brief summary:

This trial is intended to understand how the body processes repinatrabit in people with moderate liver impairment and severe kidney impairment and also to compare these results with people of similar age, weight, and sex who have normal liver function.

Conditions

Phenylketonuria

Study ID

NCT07713758

Start date

Jul 17, 2026

Status verified date

Aug, 2026

Completion date

Feb 15, 2027

Anticipated

Primary completion date

Feb 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion criteria:

1. Body mass index (BMI) from 18.0 to 38.0 kilograms per square meter (kg/m\^2) (inclusive).
2. Able to provide written, informed consent.
3. Male participants and female participants of childbearing potential (POCBP) must agree to remain fully abstinent from intercourse where pregnancy can occur OR practice 2 different contraceptive methods, where at least one must be highly effective.
4. Otherwise be in generally good health.
5. Additional criteria for Group 1:

i. Have moderate hepatic impairment determined using Child-Pugh classification (Class B).

ii. Have relatively stable hepatic function for the duration of the study as determined by the investigator and liver function test at the time of screening or stable hepatic function 1 year prior to screening.

iii. Have normal renal function. iv. Have a clinical diagnosis of hepatic cirrhosis based on biopsy and/or clinical criteria.
6. Additional criteria for Group 2:

i. Have estimated glomerular filtration rate based on the Chronic Kidney Disease-Epidemiology Collaboration (eGFRCKD-EPI) lesser than (<) 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2) indicating severe renal impairment.

ii. Not currently be on dialysis. iii. Have relatively stable renal function as determined by eGFRCKD-EPI. 7) Additional criteria for Group 3: i. eGFRCKD-EPI greater than or equal to (≥) 90 mL/min/1.73 m\^2 indicating normal renal function.

ii. Have liver enzymes within normal limits.

Exclusion criteria:

1. Participants who are breastfeeding.
2. Participants who have a positive pregnancy test result prior to receiving the investigational medical product (IMP).
3. Participants with international normalized ratio (INR) greater than (>) 2.3. Participants with hepatic impairment with elevated INR will be excluded based on the investigator's discretion.
4. Participants with hepatic carcinoma or porto-hepatic shunts that have been surgically created or planted.
5. A history of difficulty in obtaining intravenous access.
6. The donation of blood or plasma > 250 milliliters (mL) within 30 days prior to screening or received > 50 mL of blood or plasma within 30 days prior to screening.
7. Participants who have taken an investigational drug within 30 days prior to screening.
8. Exposure to any substances known to stimulate hepatic microsomal enzymes within 30 days prior to screening (eg, occupational exposure to pesticides, organic solvents, etc).
9. Any participant who, in the opinion of the investigator, should not participate in the trial.
10. Previous exposure to repinatrabit.
11. Additional criteria for Group 1: History of serious mental disorder including participants who have greater than Grade 1 encephalopathy as assessed by the Child-Pugh score and/or the investigator's judgment.
12. Additional criteria for Group 2:

i) Participants that have undergone a renal transplant. ii) Participants expected to require dialysis within 45 days. iii) Clinically significant abnormal findings in the serum chemistry, hematology, or urinalysis results obtained at screening or on Day -1, other than those associated with underlying renal conditions and other stable medical conditions consistent with the disease processes.
13. Additional criteria for Group 3: History of or current hepatitis, or carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HC).

Note: Other protocol-specified inclusion/exclusion criteria may apply.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: Moderate Hepatic Impairment

Participants with moderate hepatic impairment will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.

experimental: Group 2: Severe Renal Impairment

Participants with severe renal impairment will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.

experimental: Group 3: Matched Normal Hepatic and Renal Function

Participants matched by age, weight, and sex with normal hepatic and renal function will receive a single dose of repinatrabit tablet, under fasted conditions on Day 1.

Interventions

Repinatrabit

Oral tablet

Primary outcome measure

  • Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve Calculated to the Last Observable Concentration at Time t (AUC0-t) of Repinatrabit [ Time Frame: From Day 1 to Day 8 ]
  • Groups 1 and 2: Unbound and Total Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Repinatrabit [ Time Frame: From Day 1 to Day 8 ]
  • Groups 1 and 2: Unbound and Total Maximum (Peak) Plasma Concentration (Cmax) of Repinatrabit [ Time Frame: From Day 1 to Day 8 ]

Central Contacts and Locations

Locations

Panax Clinical Research

Recruiting

Miami, Florida, United States, 33014

More Information

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc. on 2026-08-12.