Tepotinib Hepatic Impairment Trial

Part of paid clinical trials in Miami, Florida.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT03546608
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Tepotinib — DRUG
    Participants received a single oral dose of tepotinib in Part 1.

Study Details

The study investigated the effect of various degrees of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of tepotinib.

Key Dates

First listed
Jun 6, 2018
Start date
Jun 13, 2018
Status verified
Mar 2024
Primary completion
Feb 5, 2019
Completion
Feb 5, 2019

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Healthy Participants (Control)
    Participants with normal hepatic function matched to moderate hepatic impairment received single oral dose of 500 milligrams (mg) of tepotinib film-coated tablet on Day 1 after a standard breakfast.
  • Experimental: Mild Hepatic Impairment (Child-Pugh Class A)
    Participants with mild hepatic impairment (Child-Pugh Class A, score 5 to 6) received single oral dose of 500 mg tepotinib film-coated tablet on Day 1 after a standard breakfast.
  • Experimental: Moderate Hepatic Impairment (Child-Pugh Class B)
    Participants with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) received single oral dose of 500 mg tepotinib film-coated tablet on Day 1 after a standard breakfast.

Primary Outcome Measure

Area Under the Plasma Concentration Time Curve From Time Zero to Infinity ( AUC0-inf ) of Tepotinib [ Time Frame: Pre-dose and 0.25, 0.5, 0.75, 1.0, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336 and 504 hours (for hepatic impaired participants only) post-dose on Day 1 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Qps Mra, LlcMiamiFlorida33143-
Orlando Clinical Research CenterOrlandoFlorida32809-

Find similar trials in Miami, FL

By research site
Qps Mra, Llc· Miami, FLOrlando Clinical Research Center· Orlando, FL

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