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

An Open-label, 2-Period, Fixed-sequence, Phase 1 Study in Healthy Volunteers to Evaluate the Effect of Itraconazole, a Potent CYP3A Inhibitor, on the Pharmacokinetics of Olinciguat (IW-1701)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03892499

Enrollment

Registered

2019-03-27

Start date

2019-05-03

Completion date

2019-07-03

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGOlinciguat

Oral Tablet

DRUGItraconazole

Oral Capsule

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026