A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of the Soluble Guanylate Cyclase Stimulator, Olinciguat (IW-1701), in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Olinciguat; Drug: Itraconazole

• Registration Number: NCT03892499
• Lead Sponsor: Cyclerion Therapeutics

Brief Summary

To evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme \[CYP\]3A inhibitor) on the pharmacokinetics (PK) of olinciguat

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Study Start: 2019-05-03
• Primary Completion: 2019-06-23
• Status Verified: 2019-07
• Study Completion: 2019-07-03
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

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

Inclusion Criteria

• Subject is an ambulatory adult and between 18 and 55 years old (inclusive) 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 kg/m2 at the screening visit
• Women of reproductive potential must have a negative pregnancy test at screening at at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and until 90 days after receiving the final study drug dose
• Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and until 90 days after receiving the final study drug dose
• Other inclusion criteria per protocol

Exclusion Criteria

• Any active or unstable clinically significant medical condition
• Use of any prescribed or non-prescribed medication (except for hormonal birth control)
• Other exclusion criteria per protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Olinciguat	Period 1: Single dose of olinciguat. Period 2: ITZ is dosed once daily (QD) for 10 days; a single dose of olinciguat is administered 1 hour after the fourth ITZ QD dose.
Healthy Volunteers	Itraconazole	Period 1: Single dose of olinciguat. Period 2: ITZ is dosed once daily (QD) for 10 days; a single dose of olinciguat is administered 1 hour after the fourth ITZ QD dose.

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration time curve from time zero (predose) extrapolated to infinity (AUCinf)	Predose and up to 8 days post first olinciguat dose
Maximum Observed Plasma Concentration (Cmax) of olinciguat	Predose and up to 8 days post first olinciguat dose

Secondary Outcome Measures

Name	Time	Method
Number of subjects with ≥1 treatment-emergent adverse event (TEAE) in Period 1 vs Period 2	51 days post first olinciguat dose
Cmax of Itraconazole	First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days)
Area under the concentration-time curve during a dosing interval (AUCtau) for itraconazole and hydroxy-itraconazole	Period 2 (Period 2 duration can be up to 13 days) predose and up to 24 hour after 2nd olinciguat dose
Cmax of hydroxy-Itraconazole	First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days)

Trial Locations

Locations (1)

PPD; 🇺🇸 Austin, Texas, United States