Healthy VolunteersPhase 1NCT03795519
A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male Volunteers
A Phase 1 study testing [14C]-olinciguat in people with Healthy Volunteers, run by Cyclerion Therapeutics at 1 site in United States.
Trial summary
The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of [14C]-olinciguat. 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]-olinciguat
- 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
- 17 Jan 2019to 27 Feb 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
About this study
Official title: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Olinciguat ([14C]-IW-1701) Following a Single Oral Dose in Healthy Male Subjects
The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of [14C]-olinciguat.
Read the detailed description
OLI-103 is a Phase 1 open-label, nonrandomized, single-dose study in up to 8 subjects that will be conducted at a single center in the US. Safety assessments will be performed throughout the clinic period and multiple PK samples will be collected. Subjects will be confined to the clinical research center for at least 8 days.
The purpose of the study is to determine the absorption, metabolism, and excretion of [14C]-olinciguat and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces after a single oral dose. The study will help identify and characterize olinciguat metabolites, evaluate the likelihood of effects of liver or kidney impairment on the disposition of olinciguat, and assess the likelihood of drug-drug interactions with olinciguat.
- Conditions
- Healthy Volunteers
- Being tested
- [14C]-olinciguat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-olinciguatDrug
Also called 14C-IW-1701
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Healthy Male Volunteers | Experimental | Single oral dose of [14C]-olinciguat Receives: Drug: [14C]-olinciguat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of total radioactivity excreted in urine (Aeu) and feces (Aef)
Measured: up to Day 15
Cumulative Aeu and cumulative Aef
Measured: up to Day 15
Percentage of total radioactivity excreted in urine (feu) and feces (fef)
Measured: up to Day 15
Cumulative feu and cumulative fef
Measured: up to Day 15
Percentage of total radioactivity in total excreta (feces + urine)
Measured: up to Day 15
Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of olinciguat in plasma
Measured: up to Day 15
AUC0-inf of total radioactivity in plasma and whole blood
Measured: up to Day 15
AUC from time zero to the last quantifiable concentration (AUC0-last) of olinciguat in plasma
Measured: up to Day 15
AUC0-last of total radioactivity in plasma and whole blood
Measured: up to Day 15
Maximum observed concentration (Cmax) of olinciguat in plasma
Measured: up to Day 15
Cmax of total radioactivity in plasma and whole blood
Measured: up to Day 15
Time of Cmax (Tmax) of olinciguat in plasma
Measured: up to Day 15
Tmax of total radioactivity in plasma and whole blood
Measured: up to Day 15
Apparent terminal elimination half-life (t1/2) of olinciguat in plasma
Measured: up to Day 15
t1/2 total radioactivity in plasma and whole blood
Measured: up to Day 15
Apparent total clearance of olinciguat (CL/F)
Measured: up to Day 15
Apparent volume of distribution of olinciguat (Vz/F)
Measured: up to Day 15
AUC0-inf of plasma olinciguat concentration relative to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Plasma Olinciguat/Plasma Total Radioactivity)
Measured: 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)
Measured: up to Day 15
Secondary outcomes (11)
Levels of metabolite radioactivity excreted in urine and feces
Measured: up to Day 15
AUC0-inf of metabolite radioactivity levels in plasma
Measured: 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)
Measured: up to Day 15
Chromatographic retention time of metabolites
Measured: up to Day 15
Molecular ion mass of metabolites
Measured: up to Day 15
Characteristic mass spectrometry fragmentation ions of metabolites
Measured: up to Day 15
Chemical structures (graphical representations showing atom connectivity) proposed for plasma, urine, and feces metabolites
Measured: up to Day 15
Number(s) of participants with ≥1 treatment-emergent serious adverse event (SAE)
Measured: up to Day 15
Number(s) of participants with ≥1 adverse event (AE) leading to study drug discontinuation
Measured: up to Day 15
Number(s) of participants with ≥1 Grade ≥3 AE (per CTCAE v. 5.0)
Measured: up to Day 15
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.
- First posted7 Jan 2019
- Study start17 Jan 2019
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cyclerion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bina Tejura, MD, Study director, Ironwood Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795519
- Sponsor's protocol ID
- OLI-103
- Status last verified
- Apr 2019
- First submitted
- 14 Dec 2018
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Olinciguat ([14C]-IW-1701) Following a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03795519
- Acronym / sponsor ID
- OLI-103
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cyclerion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to characterize the pharmacokinetics (PK) of olinciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of [14C]-olinciguat.
Detailed description
OLI-103 is a Phase 1 open-label, nonrandomized, single-dose study in up to 8 subjects that will be conducted at a single center in the US. Safety assessments will be performed throughout the clinic period and multiple PK samples will be collected. Subjects will be confined to the clinical research center for at least 8 days.
The purpose of the study is to determine the absorption, metabolism, and excretion of [14C]-olinciguat and to characterize and determine, where possible, the metabolites present in plasma, urine, and feces after a single oral dose. The study will help identify and characterize olinciguat metabolites, evaluate the likelihood of effects of liver or kidney impairment on the disposition of olinciguat, and assess the likelihood of drug-drug interactions with olinciguat.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Male Volunteers | Experimental | Drug: [14C]-olinciguatSingle oral dose of [14C]-olinciguat |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Any active or unstable clinically significant medical condition
- Use of any prescribed or non-prescribed medication
- Additional inclusion/exclusion criteria may apply per protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-olinciguatAlso: 14C-IW-1701oral capsule | Drug | Healthy Male Volunteers |
Primary outcome
Amount of total radioactivity excreted in urine (Aeu) and feces (Aef)
Time frame: up to Day 15
Cumulative Aeu and cumulative Aef
Time frame: up to Day 15
Percentage of total radioactivity excreted in urine (feu) and feces (fef)
Time frame: up to Day 15
Cumulative feu and cumulative fef
Time frame: up to Day 15
Percentage of total radioactivity in total excreta (feces + urine)
Time frame: up to Day 15
Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of olinciguat in plasma
Time frame: up to Day 15
AUC0-inf of total radioactivity in plasma and whole blood
Time frame: up to Day 15
AUC from time zero to the last quantifiable concentration (AUC0-last) of olinciguat in plasma
Time frame: up to Day 15
AUC0-last of total radioactivity in plasma and whole blood
Time frame: up to Day 15
Maximum observed concentration (Cmax) of olinciguat in plasma
Time frame: up to Day 15
Cmax of total radioactivity in plasma and whole blood
Time frame: up to Day 15
Time of Cmax (Tmax) of olinciguat in plasma
Time frame: up to Day 15
Tmax of total radioactivity in plasma and whole blood
Time frame: up to Day 15
Apparent terminal elimination half-life (t1/2) of olinciguat in plasma
Time frame: up to Day 15
t1/2 total radioactivity in plasma and whole blood
Time frame: up to Day 15
Apparent total clearance of olinciguat (CL/F)
Time frame: up to Day 15
Apparent volume of distribution of olinciguat (Vz/F)
Time frame: up to Day 15
AUC0-inf of plasma olinciguat concentration relative to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Plasma Olinciguat/Plasma Total Radioactivity)
Time frame: 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)
Time frame: up to Day 15
11 secondary outcomes
Levels of metabolite radioactivity excreted in urine and feces
Time frame: up to Day 15
AUC0-inf of metabolite radioactivity levels in plasma
Time frame: 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)
Time frame: up to Day 15
Chromatographic retention time of metabolites
Time frame: up to Day 15
Molecular ion mass of metabolites
Time frame: up to Day 15
Characteristic mass spectrometry fragmentation ions of metabolites
Time frame: up to Day 15
Chemical structures (graphical representations showing atom connectivity) proposed for plasma, urine, and feces metabolites
Time frame: up to Day 15
Number(s) of participants with ≥1 treatment-emergent serious adverse event (SAE)
Time frame: up to Day 15
Number(s) of participants with ≥1 adverse event (AE) leading to study drug discontinuation
Time frame: up to Day 15
Number(s) of participants with ≥1 Grade ≥3 AE (per CTCAE v. 5.0)
Time frame: up to Day 15
Number(s) of participants with ≥1 clinically significant abnormal physical examination finding
Time frame: up to Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bina Tejura, MD study director
Ironwood Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-olinciguat 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 3 Apr 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?
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 3 Apr 2019.