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

NCT03892499 | Completed Phase 1 FDA Drug

• 1 other identifier: OLI-105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) of olinciguat

  Predose and up to 8 days post first olinciguat dose

• 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

Secondary Outcomes (4)

• 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)

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

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.

Drug: Olinciguat; Drug: Itraconazole

Interventions

Olinciguat DRUG

Oral Tablet

Also known as: IW-1701

Healthy Volunteers

Itraconazole DRUG

Oral Capsule

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cyclerion Therapeutics: lead

Study Sites (1)

PPD

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bina Tejura, MD

  Cyclerion Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: May 3, 2019
• Primary Completion: June 23, 2019
• Study Completion: July 3, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)