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Completed

NCT Number: NCT03818295

A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male Volunteers

The primary objective is to characterize the pharmacokinetics (PK) of praliciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of [14C]-praliciguat.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males of any race, between 18 and 55 years of age, inclusive
  • Body mass index between 18 and 32 kg/m2, inclusive
  • Subject is in good health and has no clinically significant findings on physical examination
  • Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least 90 days after the final dose of study drug

Exclusion criteria

  • Any active or unstable clinically significant medical condition
  • Use of any prescribed or non-prescribed medication

Additional inclusion/exclusion criteria may apply per protocol

Treatment and study plan

[14C]-praliciguat

Drug

10 mg praliciguat containing approximately 500 μCi of [14C]-praliciguat

Other names: [14C]-IW-1973

Primary outcomes

  1. Amount of total radioactivity excreted in urine (Aeu) and feces (Aef)

    Time frame: up to Day 15

  2. Cumulative Aeu and cumulative Aef

    Time frame: up to Day 15

  3. Percentage of total radioactivity excreted in urine (feu) and feces (fef)

    Time frame: up to Day 15

  4. Cumulative feu and cumulative fef

    Time frame: up to Day 15

  5. Percentage of total radioactivity in total excreta (feces + urine)

    Time frame: up to Day 15

  6. Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of praliciguat in plasma

    Time frame: up to Day 15

  7. AUC0-inf of total radioactivity in plasma and whole blood

    Time frame: up to Day 15

  8. AUC from time zero to the last quantifiable concentration (AUC0-last) of praliciguat in plasma

    Time frame: up to Day 15

  9. AUC0-last of total radioactivity in plasma and whole blood

    Time frame: up to Day 15

  10. Maximum observed concentration (Cmax) of praliciguat in plasma

    Time frame: up to Day 15

  11. Cmax of total radioactivity in plasma and whole blood

    Time frame: up to Day 15

  12. Time of Cmax (Tmax) of praliciguat in plasma

    Time frame: up to Day 15

  13. Tmax of total radioactivity in plasma and whole blood

    Time frame: up to Day 15

  14. Apparent terminal elimination half-life (t1/2) of praliciguat in plasma

    Time frame: up to Day 15

  15. t1/2 total radioactivity in plasma and whole blood

    Time frame: up to Day 15

  16. Apparent total clearance of praliciguat (CL/F)

    Time frame: up to Day 15

  17. Apparent volume of distribution of praliciguat (Vz/F)

    Time frame: up to Day 15

  18. AUC0-inf of plasma praliciguat concentration relative to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Plasma Praliciguat/Plasma Total Radioactivity)

    Time frame: up to Day 15

  19. AUC0-inf of whole blood total radioactivity to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Blood Total Radioactivity/Plasma Total Radioactivity)

    Time frame: up to Day 15

Secondary outcomes

  1. Levels of metabolite radioactivity excreted in urine and feces

    Time frame: up to Day 15

  2. AUC0-inf of metabolite radioactivity levels in plasma

    Time frame: up to Day 15

  3. AUC0-inf of plasma metabolite radioactivity levels relative to AUC0-inf of plasma total radioactivity (Plasma AUC0-inf Ratio of Metabolite Radioactivity/Total Radioactivity)

    Time frame: up to Day 15

  4. Chromatographic retention time of metabolites

    Time frame: up to Day 15

  5. Molecular ion mass of metabolites

    Time frame: up to Day 15

  6. Characteristic mass spectrometry fragmentation ions of metabolites

    Time frame: up to Day 15

  7. Chemical structures (graphical representations showing atom connectivity) proposed for plasma, urine, and feces metabolites

    Time frame: up to Day 15

  8. Number(s) of participants with ≥1 treatment-emergent serious adverse event (SAE)

    Time frame: up to Day 15

  9. Number(s) of participants with ≥1 adverse event (AE) leading to study drug discontinuation

    Time frame: up to Day 15

  10. Number(s) of participants with ≥1 Grade ≥3 AE (per CTCAE v. 5.0)

    Time frame: up to Day 15

  11. Number(s) of participants with ≥1 clinically significant abnormal physical examination finding

    Time frame: up to Day 15

Sponsors and collaborators

Lead sponsor

Cyclerion Therapeutics

Industry

Registry information

Official study title

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Praliciguat ([14C]-IW-1973) Following a Single Oral Dose in Healthy Male Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2019
Registry last updated
Jun 19, 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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