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CompletedNCT03962049Updated Jan 13, 2020

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

A Phase 1 interventional study of Linzagolix in Hepatic Impairment and Healthy Participants, sponsored by ObsEva SA. Completed at 2 sites in United States. Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by ObsEva SA · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Oct 2019, 7 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
Female
01

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

Read the 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.

02

Conditions studied

  • Hepatic Impairment
  • Healthy Participants

Keywords

  • Linzagolix
  • OBE2109
  • Hepatic Impairment
  • Hepatic Insufficiency
  • Liver Diseases
  • Clinical pharmacology study
03

In context

Hepatic Insufficiency

329 studies on the registry are indexed under Hepatic Insufficiency; 53 are open to participants now.

This study's enrollment of 24 is below the median of 36 across 222 interventional studies indexed under Hepatic Insufficiency.

Browse Hepatic Insufficiency studies →

Lead sponsor

ObsEva SA is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Key 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.

Key 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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Normal Hepatic Function

    Healthy participants with Normal Hepatic Function

    Drug: Linzagolix

  • Experimental
    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)

    Drug: Linzagolix

  • Experimental
    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)

    Drug: Linzagolix

  • Experimental
    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)

    Drug: Linzagolix

Interventions

  • DrugLinzagolix

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

06

What researchers measure

Primary outcomes

  1. Plasma pharmacokinetic (PK) parameter Cmax of linzagolix and of KP017

    Measurement of effect of hepatic impairment on PK of linzagolix and its metabolite KP017 by assessment of the maximum plasma concentration (Cmax). Cmax directly determined from the plasma concentration-time profiles

    Time frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose

  2. Plasma PK parameter Tmax of linzagolix and of KP017

    Measurement of effect of hepatic impairment on PK of linzagolix and its metabolite KP017 by assessment of the Time to reach Cmax (Tmax)

    Time frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose

  3. Plasma PK parameter AUC0-t of linzagolix and of KP017

    Measurement of effect of hepatic impairment on PK of linzagolix and its metabolite KP017 by assessment of the AUC0-t (area under the concentration time curve, from time 0 to the last observed non-zero concentration)

    Time frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose

  4. Plasma PK parameter T1/2 of linzagolix and of KP017

    Measurement of effect of hepatic impairment on PK of linzagolix and its metabolite KP017 by assessment of the T1/2 (Terminal half life)

    Time frame: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose

Secondary outcomes

  1. Treatment emergent Adverse Events

    Assessment of safety and tolerability of a single dose of linzagolix in hepatic impaired subjects compared with healthy control subjects by assessing the number, frequency and severity of treatment emergent Adverse Events

    Time frame: Day 1 to 14 days post-dose

07

Study locations

2 sites
  • Clinical Site
    Hialeah, Florida 33014, United States
  • Clinical Site
    Orlando, Florida 32809, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03962049
Lead sponsor
ObsEva SA
Responsible party
Sponsor
First posted
May 23, 2019
Start date
May 15, 2019
Primary completion
Oct 23, 2019
Completion
Nov 1, 2019
Last update
Jan 13, 2020

Study contacts

ObsEva SA
study director · Geneva

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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