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OpenTrials
Completed

NCT Number: NCT03892499

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olinciguat

Drug

Oral Tablet

Other names: IW-1701

Itraconazole

Drug

Oral Capsule

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of olinciguat

    Time frame: Predose and up to 8 days post first olinciguat dose

  2. Area under the plasma concentration time curve from time zero (predose) extrapolated to infinity (AUCinf)

    Time frame: Predose and up to 8 days post first olinciguat dose

Secondary outcomes

  1. Number of subjects with ≥1 treatment-emergent adverse event (TEAE) in Period 1 vs Period 2

    Time frame: 51 days post first olinciguat dose

  2. Cmax of Itraconazole

    Time frame: First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days)

  3. Area under the concentration-time curve during a dosing interval (AUCtau) for itraconazole and hydroxy-itraconazole

    Time frame: Period 2 (Period 2 duration can be up to 13 days) predose and up to 24 hour after 2nd olinciguat dose

  4. Cmax of hydroxy-Itraconazole

    Time frame: First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days)

Sponsors and collaborators

Lead sponsor

Cyclerion Therapeutics

Industry

Registry information

Official study title

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)

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2019
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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