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

Sponsor

Cyclerion Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT03818295

Collaborator

(none)

Enrollment

Location

Arm

1.8

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: [14C]-praliciguat	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official 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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Apr 24, 2019

Actual Study Completion Date :

Apr 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy Male Volunteers Single oral dose of [14C]-praliciguat	Drug: [14C]-praliciguat 10 mg praliciguat containing approximately 500 μCi of [14C]-praliciguat Other Names: [14C]-IW-1973

Arm

Intervention/Treatment

Experimental: Healthy Male Volunteers

Single oral dose of [14C]-praliciguat

Drug: [14C]-praliciguat

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

Other Names:

[14C]-IW-1973

Outcome Measures

Primary Outcome Measures

Amount of total radioactivity excreted in urine (Aeu) and feces (Aef) [up to Day 15]
Cumulative Aeu and cumulative Aef [up to Day 15]
Percentage of total radioactivity excreted in urine (feu) and feces (fef) [up to Day 15]
Cumulative feu and cumulative fef [up to Day 15]
Percentage of total radioactivity in total excreta (feces + urine) [up to Day 15]
Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of praliciguat in plasma [up to Day 15]
AUC0-inf of total radioactivity in plasma and whole blood [up to Day 15]
AUC from time zero to the last quantifiable concentration (AUC0-last) of praliciguat in plasma [up to Day 15]
AUC0-last of total radioactivity in plasma and whole blood [up to Day 15]
Maximum observed concentration (Cmax) of praliciguat in plasma [up to Day 15]
Cmax of total radioactivity in plasma and whole blood [up to Day 15]
Time of Cmax (Tmax) of praliciguat in plasma [up to Day 15]
Tmax of total radioactivity in plasma and whole blood [up to Day 15]
Apparent terminal elimination half-life (t1/2) of praliciguat in plasma [up to Day 15]
t1/2 total radioactivity in plasma and whole blood [up to Day 15]
Apparent total clearance of praliciguat (CL/F) [up to Day 15]
Apparent volume of distribution of praliciguat (Vz/F) [up to Day 15]
AUC0-inf of plasma praliciguat concentration relative to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Plasma Praliciguat/Plasma Total Radioactivity) [up to Day 15]
AUC0-inf of whole blood total radioactivity to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Blood Total Radioactivity/Plasma Total Radioactivity) [up to Day 15]

Secondary Outcome Measures

Levels of metabolite radioactivity excreted in urine and feces [up to Day 15]
AUC0-inf of metabolite radioactivity levels in plasma [up to Day 15]
AUC0-inf of plasma metabolite radioactivity levels relative to AUC0-inf of plasma total radioactivity (Plasma AUC0-inf Ratio of Metabolite Radioactivity/Total Radioactivity) [up to Day 15]
Chromatographic retention time of metabolites [up to Day 15]
Molecular ion mass of metabolites [up to Day 15]
Characteristic mass spectrometry fragmentation ions of metabolites [up to Day 15]
Chemical structures (graphical representations showing atom connectivity) proposed for plasma, urine, and feces metabolites [up to Day 15]
Number(s) of participants with ≥1 treatment-emergent serious adverse event (SAE) [up to Day 15]
Number(s) of participants with ≥1 adverse event (AE) leading to study drug discontinuation [up to Day 15]
Number(s) of participants with ≥1 Grade ≥3 AE (per CTCAE v. 5.0) [up to Day 15]
Number(s) of participants with ≥1 clinically significant abnormal physical examination finding [up to Day 15]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit Inc.	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

Cyclerion Therapeutics

Investigators

Study Director: John Hanrahan, MD, Ironwood Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cyclerion Therapeutics

ClinicalTrials.gov Identifier:

NCT03818295

Other Study ID Numbers:

PRL-105

First Posted:

Jan 28, 2019

Last Update Posted:

Jun 19, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Praliciguat

Study Results

No Results Posted as of Jun 19, 2019