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Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function

NCT03962049 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-01-13

No results posted yet for this study

Summary

The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired hepatic function compared to match control subjects with normal hepatic function

Conditions

  • Hepatic Impairment
  • Healthy Participants

Interventions

DRUG

Linzagolix

A single dose of 200 mg linzagolix (2 tablets of 100 mg) will be administered orally under fasting conditions

Sponsors & Collaborators

  • ObsEva SA

    lead INDUSTRY

Principal Investigators

  • ObsEva SA · Geneva

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2019-10-23
Completion
2019-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03962049 on ClinicalTrials.gov