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Bile Acid Sequestrant

Linerixibat for Itching

Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 17 to 19 and days 35 to 38
Awards & highlights

Study Summary

This trial looks at whether taking linerixibat with OCA affects the levels of OCA in the blood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 17 to 19 and days 35 to 38
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 17 to 19 and days 35 to 38 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average trough concentration (Ctrough) in plasma for total-OCA at steady state
Secondary outcome measures
AUC from time 0 to 24 hour (AUC0-24) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Area under the concentration curve from time 0 to t (AUC0-t) for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
Average trough concentration (Ctrough) in plasma for OCA, tauro-OCA, glyco-OCA and total-OCA at steady state
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Treatment Arm 4Experimental Treatment2 Interventions
Participants will receive OCA at dose level 2, 4 hours after the linerixibat administration
Group II: Treatment Arm 3Experimental Treatment2 Interventions
Participants will receive OCA at dose level 1 along with linerixibat
Group III: Treatment Arm 2Experimental Treatment2 Interventions
Participants will receive OCA at dose level 2 along with linerixibat
Group IV: Treatment Arm 1Experimental Treatment2 Interventions
Participants will receive OCA at dose level 1, 4 hours after the linerixibat administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obeticholic acid
2012
Completed Phase 2
~230
Linerixibat
2022
Completed Phase 1
~60

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,749 Previous Clinical Trials
8,067,384 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,886 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants
2021. "Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05133830.
~16 spots leftby Apr 2025
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