How Repinatrabit is processed in adults with liver or kidney impairment versus normal function
Official title: A Phase 1, Open-label, Single-dose, Parallel-group Study Evaluating the Pharmacokinetics of Oral Repinatrabit (JNT-517) Immediate Release Tablet in Hepatic or Renal Impaired Adult Participants Matched to Adult Participants With Normal Hepatic and Renal Function
Run by Otsuka Pharmaceutical Development & Commercialization, Inc. · NCT07713758 · Data updated 2026-11-12
This study tests how Repinatrabit is handled by the body in adults with moderate liver impairment or severe kidney impairment compared to adults with normal liver function.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | July 17, 2026 |
| Main results expected | February 9, 2027 |
| Study ends | February 15, 2027 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07713758 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with BMI 18.0–38.0 kg/m2, able to consent, including Group 1: moderate hepatic impairment (Child-Pugh B) with cirrhosis and stable function; Group 2: kidney impairment as defined by study criteria; all otherwise healthy aside from the specified conditions.
✕Probably not a fit
Participants with impairment types not meeting Group 1 or Group 2 criteria or whose impairment does not affect drug processing may not experience benefit from this pharmacokinetic assessment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 study compares the pharmacokinetics of Repinatrabit in adults with moderate hepatic impairment (Child-Pugh B) and/or severe renal impairment to adults with normal liver function. It evaluates how the drug is absorbed, distributed, metabolized, and excreted in these groups. Eligible participants include adults with BMI 18.0–38.0 kg/m2 who can give informed consent, with additional criteria defining Group 1 (moderate liver impairment and cirrhosis) and Group 2 (kidney impairment). The study is conducted at Panax Clinical Research in Miami, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Why it matters
Potential benefit: If successful, the study could inform safer and more effective dosing for Repinatrabit in people with liver or kidney impairment.
How similar studies have gone: Early pharmacokinetic studies in similar designs have shown the importance of organ function on drug processing, but this specific comparison with Repinatrabit is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Panax Clinical Research
Miami, Florida, United States Recruiting
Study contacts
- Study coordinator: Otsuka Call Center
- Email: Otsuka-ProfessionalServices@otsuka-us.com
- Phone: 844-687-8522
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.