A Phase 1, Open Label, Parallel Group Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics of Ribupatide in Healthy Participants and in Participants Living With Severe Renal Impairment or End Stage Kidney Disease

Kailera

Summary

The primary objective of the study is to estimate the PK parameters of ribupatide in participants with severe renal impairment or end-stage kidney disease (ESKD) after a single dose of ribupatide subcutaneous (SC) injection compared with participants with normal renal function.

Eligibility

Age range: 18–85 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Body mass index ≥18.5 at Screening. * Female Participants: Must not be pregnant or planning to be pregnant or breastfeeding or planning to breastfeed during the study and for at least 35 days after the study drug dose. * Female participants: Must have a negative serum pregnancy test at Screening. * Suitable venous access for blood sampling. Exclusion Criteria: * History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, inc…

Interventions

Drug
Ribupatide
SC Injection

Locations (2)

Kailera Clinical Site
Orlando, Florida
Kailera Clinical Site
San Antonio, Texas

A Phase 1, Open Label, Parallel Group Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics of Ribupatide in Healthy Participants and in Participants Living With Severe Renal Impairment or End Stage Kidney Disease

Summary

Eligibility

Interventions

Locations (2)

Compensation

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Details

Conditions