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

NCT ID: NCT03962049

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2019-11-01

Brief 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

Detailed Description

This is a Phase 1, non-randomized, open label, single-dose study to evaluate the effect of varying degrees of impaired hepatic function (i.e., mild, moderate, and severe Hepatic Impairment (HI)) on the PK, safety, and tolerability of linzagolix and its major metabolite, KP017.

Up to 28 adult female participants will be enrolled.

Conditions

Hepatic Impairment; Healthy Participants

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Normal Hepatic Function

Healthy participants with Normal Hepatic Function

Group Type: EXPERIMENTAL

Linzagolix

Intervention Type: DRUG

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

Mild Hepatic Impairment

Presence of Mild Hepatic Impairment (score of 5 to 6, on the Child Pugh scale and with features of cirrhosis due to any etiology)

Group Type: EXPERIMENTAL

Linzagolix

Intervention Type: DRUG

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

Moderate Hepatic Impairment

Presence of Moderate Hepatic Impairment (score of 7 to 9, on the Child Pugh scale and with features of cirrhosis due to any etiology)

Group Type: EXPERIMENTAL

Linzagolix

Intervention Type: DRUG

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

Severe Hepatic Impairment

Presence of Severe Hepatic Impairment (score of 10 to 15 on the Child Pugh scale and with features of cirrhosis due to any etiology)

Group Type: EXPERIMENTAL

Linzagolix

Intervention Type: DRUG

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

Interventions

Linzagolix

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Hepatic Impaired Subjects

1. Adult female, 18-75 years of age, inclusive, at screening

2. Has a BMI ≥ 18.0 and ≤ 42.0 kg/m^2 and weight ≥ 40 kg, at screening

3. Aside from HI, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, electrocardiograms (ECGs), and screening clinical laboratory profiles, as deemed by the Principal Investigator (PI) or designee

4. Has a score on the Child-Pugh scale at screening as follows:

• Severe HI: ≥ 10 and ≤ 15
• Moderate HI: ≥ 7 and ≤ 9
• Mild HI: ≥ 5 and ≤ 6

5. Has a diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology

Healthy Subjects

1. Healthy adult female will be matched based upon age and BMI

2. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.

Exclusion Criteria

Hepatic Impaired Subjects

1. Has a clinically active Grade 3 or 4 encephalopathy

2. Has fluctuating or rapidly deteriorating hepatic function within the screening period, and up to 30 days prior to Day 1, in the opinion of the PI and Sponsor

3. Has history of liver or other solid organ transplant

4. Had any major surgery within 4 weeks prior to dosing

5. Has a surgical (e.g., hepatectomy, nephrectomy, digestive organ resection) or medical condition other than HI which might significantly alter the absorption, distribution, metabolism, or excretion of linzagolix and its metabolites, or which may jeopardize the subject's safety in case of participation in the study in the opinion of the PI or designee

Healthy Subjects

1. Has any clinically significant illness, as judged by the PI or designee, within 4 weeks prior to dosing

2. Has laboratory values at screening or check-in which are deemed to be clinically significant (especially derangement within liver function test), unless agreed in advance by the PI and the Sponsor

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ObsEva SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ObsEva SA

Role: STUDY_DIRECTOR

Geneva

Locations

Clinical Site

Hialeah, Florida, United States

Clinical Site

Orlando, Florida, United States

Countries

United States

Other Identifiers

18-OBE2109-009

Identifier Type: -

Identifier Source: org_study_id