Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)

Conditions

• Hypercholesterolaemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Accepted

Interventions

• Enlicitide Decanoate — DRUG
  Oral dose

Study Details

The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment (moderate, severe, end stage renal disease \[ESRD\]) to those of healthy mean matched control participants on a background of statin therapy. There is no formal hypothesis.

Key Dates

Start date

Jul 20, 2023

Status verified

Feb 2025

Primary completion

Jan 19, 2024

Completion

Jan 19, 2024

Study Design

Enrollment

33 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Panel A: Moderate Renal Impairment (RI)
  Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1
• Experimental: Panel B: Severe RI
  Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1
• Experimental: Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)
  Participants receive Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.
• Experimental: Panel D: Healthy Controls
  Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.

Primary Outcome Measure

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate [ Time Frame: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose ]

Locations (5)

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