A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: IW-1973; Drug: Itraconazole

• Registration Number: NCT03499106
• Lead Sponsor: Cyclerion Therapeutics

Brief Summary

The primary objective of the study is to evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme \[CYP\]3A inhibitor) on the pharmacokinetics of IW-1973.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-09
• Study Start: 2018-04-12
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-17
• Primary Completion: 2018-07-06
• Study Completion: 2018-07-06
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Subject is an ambulatory adult between 18 and 75 years old at the screening visit
• Subject is in good health and has no clinically significant findings on physical examination
• Body mass index is > 18 and < 30.0 kg/m2 at the screening visit
• Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 2 months after the final dose of study drug
• Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 2 months after the final dose of study drug
• Other inclusion criteria per protocol

Exclusion Criteria

• Any active or unstable clinically significant medical condition
• Use of any prescribed or non-prescribed medication
• Other exclusion criteria per protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Itraconazole	Period 1: Single dose of IW-1973. Period 2: ITZ is dosed once daily (QD) for 17 days; a single dose of IW-1973 is administered 1 hour after the fourth ITZ QD dose.
Healthy Volunteers	IW-1973	Period 1: Single dose of IW-1973. Period 2: ITZ is dosed once daily (QD) for 17 days; a single dose of IW-1973 is administered 1 hour after the fourth ITZ QD dose.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration Time Curve of IW-1973 From Time Zero Extrapolated to Infinity (AUC[0-inf])	Predose and up to 14 days post dose of IW-1973
Maximum Observed Plasma Concentration (Cmax) of IW-1973	Predose and up to 14 days post dose of IW-1973

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-last]) of IW-1973	Predose and up to 14 days post dose of IW-1973
Apparent Terminal Rate Constant (lambda[z]) of IW-1973	Predose and up to 14 days post dose of IW-1973
Apparent Total Plasma Clearance (CL/F) of IW-1973	Predose and up to 14 days post dose of IW-1973
Time to Cmax (Tmax) of IW-1973	Predose and up to 14 days post dose of IW-1973
Area Under the Concentration-Time Curve From Time Zero to 24 hours AUC(0-24) Postdose of IW-1973	Predose and up to 14 days post dose of IW-1973
Apparent Terminal Half-Life (t1/2) of IW-1973	Predose and up to 14 days post dose of IW-1973
Apparent Volume of Distribution (Vz/F) of IW-1973	Predose and up to 14 days post dose of IW-1973

Trial Locations

Locations (1)

IQVIA; 🇺🇸 Overland Park, Kansas, United States