NCT05633147 - Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 27, 2022

Primary Completion Date

May 30, 2023

Study Completion Date

May 30, 2023

Conditions

Safety IssuesPharmacokineticsDrug InteractionTolerability

Interventions

DRUG

Linaprazan glurate

"Investigational Medicinal Product: Linaprazan glurate (tablets).~Part I:~Linaprazan glurate in base form, 100 mg once daily Day 1 and Day 10.~Part II:~Linaprazan glurate hydrochloride (HCl), 75 mg twice daily for 13 days."

DRUG

Drug drug interaction (DDI) - Clarithromycin (Part I)

Index inhibitor (perpetrator drug) Clarithromycin 500 mg twice daily for 9 days (tablets).

DRUG

Drug drug interaction (DDI) - Midazolam (Part 2)

Substrate for CYP3A. Midazolam 2.5 mg once daily (2.5 mL oral solution).

Trial Locations (1)

75237

CTC Clinical Trials Consultants AB, Uppsala