- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03036501
A Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled Risdiplam (RO7034067) in Healthy Male Participants
October 2, 2018 updated by: Hoffmann-La Roche
Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled RO7034067 in Healthy Male Subjects
This is an open-label, non-randomized study investigating the excretion balance, PK and metabolism of a single oral dose of [14C]-labeled Risdiplam (RO7034067) in healthy male participants.
This study will assess the characterize mass balance, routes and rates of elimination of [14C]-labeled Risdiplam (RO7034067), using conventional analytical methods and assess the pharmacokinetics of total drug related [14C]-radioactivity, Risdiplam (RO7034067) and its metabolite(s).
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Groningen, Netherlands, 9728 NZ
- Pra International Group B.V
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male participants, 35 to 65 years of age (inclusive)
- A body mass index between 18 to 30 kg/m^2 inclusive
- Agreement to use two methods of contraception, during the treatment period and for at least 4 months after the last dose of study drug. One of the contraceptive methods must be a condom. The second contraceptive method must include one of the following: diaphragm or cervical cap, intra-uterine device or system, or oral, injected or implanted hormonal method of contraception.
- No intention of donating sperm within 4 months of study drug administration
- Able to participate and willing to give written informed consent and to comply with the study requirements and restrictions
- Fluent in the language of the Investigator and study staff and able to communicate with the study staff
Exclusion Criteria:
- Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study, place the participant at undue risk or interfere with the ability of the participant to complete the study in the opinion of the Investigator
- History of any clinically significant gastrointestinal, renal, hepatic, broncho- pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, hypofertility, cancer or cirrhosis
- Participants with any clinically significant eye pathology affecting best-corrected visual acuity, or optic neuritis retinal abnormalities on spectral domain - optical coherence tomography and 7-field fundus color photography as assessed by an ophthalmologist
- History or evidence of (neuro) muscular disorders
- History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs. Surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract
- History or evidence of skin disorders, as assessed by a thorough skin examination of the whole body
- History of malignancy in the past 5 years
- A history of clinically significant hypersensitivity (e.g., drugs, excipients) or allergic reactions
- Participants who, in the Investigator's judgment, pose a suicidal or homicidal risk, or any participant with a history of suicidal or homicidal attempts
- Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to study drug administration
- History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease
- Clinically significant abnormalities in laboratory test results
- Positive results on tests for human immunodeficiency virus (HIV)-1 or HIV-2, hepatitis C virus or hepatitis B virus
- Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of drugs of abuse
- Confirmed systolic blood pressure (SBP) greater than 150 or less than 90 mmHg, and diastolic blood pressure (DBP) greater than 95 or less than 50 mmHg
- Confirmed (based on the average of at least 3 consecutive measurements) resting pulse rate greater than 100 or less than 40 bpm
- Participation in an investigational drug or device study within 90 days prior to screening, as calculated from the day of follow-up from the previous study
- Smokers who regularly smoke more than 10 cigarettes daily or equivalent tobacco- containing products
- Dietary restrictions that would prohibit the consumption of standardized meals
- Use of any prohibited medications and food before study start and during the study
- Participants under judicial supervision, guardianship or curatorship
- Infrequent bowel movements (less than once per 24 hours on average)
- Regular work with ionizing radiation or radioactive material
- Participants who plan to attempt to father children within 4 months after study drug administration
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: [^14C]-Risdiplam
Participants will be administered with [^14C]-Risdiplam solution orally under fasted conditions on Day 1.
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[^14C]-Risdiplam 18 mg oral solution with approximately 0.75 megabecquerel MBq (20 microcuries [μCi]) of [14C]-labeled Risdiplam.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Dose Recovered as Total [14C]-radioactivity in Urine
Time Frame: Day 1 to Day 36
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Day 1 to Day 36
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Cumulative Urinary Amount of Total [14C]-Radioactivity in Urine
Time Frame: Day 1 to Day 36
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Day 1 to Day 36
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Percentage of Dose Recovered as Total [14C]-radioactivity in Feces
Time Frame: Day 1 to Day 36
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Day 1 to Day 36
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Maximum Observed Plasma Concentration (Cmax) of Risdiplam
Time Frame: Day 1 to Day 36
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Day 1 to Day 36
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Time to Maximum Observed Plasma Concentration of Risdiplam (Tmax)
Time Frame: Day 1 to Day 36
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Day 1 to Day 36
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Area Under the Plasma Concentration-time Curve from Time 0 to Last Measurable Concentration Time Point (AUC0-last)
Time Frame: Day 1 to Day 36
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Day 1 to Day 36
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Area Under Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)
Time Frame: Day 1 to Day 36
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Day 1 to Day 36
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Apparent Terminal Elimination Half-Life (t1/2)
Time Frame: Day 1 to Day 36
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Day 1 to Day 36
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants with Adverse Events
Time Frame: Up to 10 weeks
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Up to 10 weeks
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Percentage of Participants with Laboratory, ECGs, Ophthalmological Assessments, And Vital Signs Abnormalities
Time Frame: Up to 10 weeks
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Up to 10 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 3, 2017
Primary Completion (ACTUAL)
February 28, 2017
Study Completion (ACTUAL)
February 28, 2017
Study Registration Dates
First Submitted
January 26, 2017
First Submitted That Met QC Criteria
January 26, 2017
First Posted (ESTIMATE)
January 30, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 4, 2018
Last Update Submitted That Met QC Criteria
October 2, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP39122
- 2016-003461-26 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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