Health TrialsbyHealthPanel

A Study to Evaluate the Impact of Renal Impairment on the Pharmacokinetics (PK) of Ribupatide

ConditionsEnd Stage Renal DiseaseRenal ImpairmentObesityOverweight
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorKailera

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months determined by the Investigator (or delegate) to be clinically relevant.

Abnormal thyroid-stimulating hormone at Screening.

Any history of malignant disease including in situ cervical or prostate cancer within the last 5 years.

History of or positive test results at the Screening Visit for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or active hepatitis C virus (HCV) infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ribupatide

    Drug

    SC Injection

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: RibupatideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Observed Plasma Concentration (Cmax) of Ribupatide

Time frame
Predose up to 816 hours postdose on Day 35
2

Area Under Concentration Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-t) of Ribupatide

Time frame
Predose up to 816 hours postdose on Day 35
3

Area Under Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Ribupatide

Time frame
Predose up to 816 hours postdose on Day 35

Secondary outcomes

1

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
Day 1 up to Day 35

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kailera

Lead sponsor

Source ClinicalTrials.gov
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