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CompletedNCT03818295Updated Jun 19, 2019

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

A Phase 1 interventional study of [14C]-praliciguat in Healthy Volunteers, sponsored by Cyclerion Therapeutics. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-19.

Sponsored by Cyclerion Therapeutics (formerly part of Ironwood Pharmaceuticals, Inc.) · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Apr 2019, 7 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Cyclerion Therapeutics is the lead sponsor of 11 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

First submitted before Cyclerion Therapeutics left Ironwood Pharmaceuticals, Inc..

Browse Cyclerion Therapeutics studies →All Ironwood Pharmaceuticals, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Additional inclusion/exclusion criteria may apply per protocol

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Healthy Male Volunteers

    Single oral dose of \[14C\]-praliciguat

    Drug: [14C]-praliciguat

Interventions

  • Drug[14C]-praliciguat

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

    Also known as: [14C]-IW-1973

06

What researchers measure

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

07

Study locations

1 site
  • Covance Clinical Research Unit Inc.
    Madison, Wisconsin 53704, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2019 to primary completion in Apr 2019, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2019
First posted
Jan 28, 2019
StartActual
Mar 1, 2019
Primary completionActual
Apr 24, 2019
CompletionActual
Apr 24, 2019
Last update
Jun 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03818295
Lead sponsor
Cyclerion Therapeutics
Responsible party
Sponsor
First posted
Jan 28, 2019
Start date
Mar 1, 2019
Primary completion
Apr 24, 2019
Completion
Apr 24, 2019
Last update
Jun 19, 2019

Study contacts

John Hanrahan, MD
study director · Ironwood Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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