NCT03795519

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

January 17, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2019

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

1 month

First QC Date

December 14, 2018

Last Update Submit

April 1, 2019

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (19)

  • 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 olinciguat 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 olinciguat 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 olinciguat in plasma

    up to Day 15

  • Cmax of total radioactivity in plasma and whole blood

    up to Day 15

  • Time of Cmax (Tmax) of olinciguat 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 olinciguat in plasma

    up to Day 15

  • t1/2 total radioactivity in plasma and whole blood

    up to Day 15

  • Apparent total clearance of olinciguat (CL/F)

    up to Day 15

  • Apparent volume of distribution of olinciguat (Vz/F)

    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)

    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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (1)

Healthy Male Volunteers

EXPERIMENTAL

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

Drug: [14C]-olinciguat

Interventions

[14C]-olinciguatDRUG

oral capsule

Also known as: 14C-IW-1701
Healthy Male Volunteers

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

Study Officials

  • Bina Tejura, MD

    Ironwood Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2018

First Posted

January 7, 2019

Study Start

January 17, 2019

Primary Completion

February 27, 2019

Study Completion

February 27, 2019

Last Updated

April 3, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)