A Phase 1 interventional study of [14C]-olinciguat 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 2019-04-03.
Sponsored by Cyclerion Therapeutics (formerly part of Ironwood Pharmaceuticals, Inc.) · Phase 1, Interventional, and Other
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.
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.
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..
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Additional inclusion/exclusion criteria may apply per protocol
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single oral dose of \[14C\]-olinciguat
Drug: [14C]-olinciguat
oral capsule
Also known as: 14C-IW-1701
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
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
Plan to share: No
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Olinciguat