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Healthy VolunteersPhase 1NCT03818295

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

A Phase 1 study testing [14C]-praliciguat in people with Healthy Volunteers, run by Cyclerion Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
[14C]-praliciguat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
1 Mar 2019to 24 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Any active or unstable clinically significant medical condition
  • Use of any prescribed or non-prescribed medication
  • Additional inclusion/exclusion criteria may apply per protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Covance Clinical Research Unit Inc.

    Madison, Wisconsin, 53704

Other trials in United States

About this study

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

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.

Being tested
[14C]-praliciguat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]-praliciguatDrug

    Also called [14C]-IW-1973

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

Study groups in NCT03818295
Study groupRoleWhat they receive
Healthy Male VolunteersExperimentalSingle oral dose of [14C]-praliciguat
Receives: Drug: [14C]-praliciguat

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to Day 15

  2. Cumulative Aeu and cumulative Aef

    Measured: up to Day 15

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

    Measured: up to Day 15

  4. Cumulative feu and cumulative fef

    Measured: up to Day 15

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

    Measured: up to Day 15

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

    Measured: up to Day 15

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

    Measured: up to Day 15

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

    Measured: up to Day 15

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

    Measured: up to Day 15

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

    Measured: up to Day 15

  11. Cmax of total radioactivity in plasma and whole blood

    Measured: up to Day 15

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

    Measured: up to Day 15

  13. Tmax of total radioactivity in plasma and whole blood

    Measured: up to Day 15

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

    Measured: up to Day 15

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

    Measured: up to Day 15

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

    Measured: up to Day 15

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

    Measured: 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)

    Measured: 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)

    Measured: up to Day 15

Secondary outcomes (11)

  1. Levels of metabolite radioactivity excreted in urine and feces

    Measured: up to Day 15

  2. AUC0-inf of metabolite radioactivity levels in plasma

    Measured: 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)

    Measured: up to Day 15

  4. Chromatographic retention time of metabolites

    Measured: up to Day 15

  5. Molecular ion mass of metabolites

    Measured: up to Day 15

  6. Characteristic mass spectrometry fragmentation ions of metabolites

    Measured: up to Day 15

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

    Measured: up to Day 15

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

    Measured: up to Day 15

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

    Measured: up to Day 15

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

    Measured: up to Day 15

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

    Measured: up to Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2019
  2. Study start1 Mar 2019
  3. Primary completion24 Apr 2019
  4. Study completion24 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03818295
Sponsor's protocol ID
PRL-105
Status last verified
Jun 2019
First submitted
24 Jan 2019
Last updated
19 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-praliciguat in people with Healthy Volunteers, run by Cyclerion Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of total radioactivity excreted in urine (Aeu) and feces (Aef) (time frame: up to Day 15). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03818295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.

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