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Completed

NCT Number: NCT03499106

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

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.

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Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

IQVIA

Overland Park, Kansas, 66211, 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 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

Treatment and study plan

IW-1973

Drug

Oral Tablet

Itraconazole

Drug

Oral Capsule

Primary outcomes

  1. Area Under the Plasma Concentration Time Curve of IW-1973 From Time Zero Extrapolated to Infinity (AUC[0-inf])

    Time frame: Predose and up to 14 days post dose of IW-1973

  2. Maximum Observed Plasma Concentration (Cmax) of IW-1973

    Time frame: Predose and up to 14 days post dose of IW-1973

Secondary outcomes

  1. Time to Cmax (Tmax) of IW-1973

    Time frame: Predose and up to 14 days post dose of IW-1973

  2. Area Under the Concentration-Time Curve From Time Zero to 24 hours AUC(0-24) Postdose of IW-1973

    Time frame: Predose and up to 14 days post dose of IW-1973

  3. Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-last]) of IW-1973

    Time frame: Predose and up to 14 days post dose of IW-1973

  4. Apparent Terminal Half-Life (t1/2) of IW-1973

    Time frame: Predose and up to 14 days post dose of IW-1973

  5. Apparent Terminal Rate Constant (lambda[z]) of IW-1973

    Time frame: Predose and up to 14 days post dose of IW-1973

  6. Apparent Total Plasma Clearance (CL/F) of IW-1973

    Time frame: Predose and up to 14 days post dose of IW-1973

  7. Apparent Volume of Distribution (Vz/F) of IW-1973

    Time frame: Predose and up to 14 days post dose of IW-1973

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 IW-1973

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2018
Registry last updated
Apr 3, 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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