HealthyPhase 1NCT03036501
A Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled Risdiplam (RO7034067) in Healthy Male Participants
A Phase 1 study testing [^14C]-Risdiplam in people with Healthy, run by Hoffmann-La Roche at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [^14C]-Risdiplam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Jan 2017to 28 Feb 2017
- Phase
- Phase 1
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 35 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Healthy
- Being tested
- [^14C]-Risdiplam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[^14C]-RisdiplamDrug
[^14C]-Risdiplam 18 mg oral solution with approximately 0.75 megabecquerel MBq (20 microcuries [μCi]) of [14C]-labeled Risdiplam.
| Study group | Role | What they receive |
|---|---|---|
| [^14C]-Risdiplam | Experimental | Participants will be administered with [^14C]-Risdiplam solution orally under fasted conditions on Day 1. Receives: Drug: [^14C]-Risdiplam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Dose Recovered as Total [14C]-radioactivity in Urine
Measured: Day 1 to Day 36
Cumulative Urinary Amount of Total [14C]-Radioactivity in Urine
Measured: Day 1 to Day 36
Percentage of Dose Recovered as Total [14C]-radioactivity in Feces
Measured: Day 1 to Day 36
Maximum Observed Plasma Concentration (Cmax) of Risdiplam
Measured: Day 1 to Day 36
Time to Maximum Observed Plasma Concentration of Risdiplam (Tmax)
Measured: Day 1 to Day 36
Area Under the Plasma Concentration-time Curve from Time 0 to Last Measurable Concentration Time Point (AUC0-last)
Measured: Day 1 to Day 36
Area Under Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)
Measured: Day 1 to Day 36
Apparent Terminal Elimination Half-Life (t1/2)
Measured: Day 1 to Day 36
Secondary outcomes (2)
Percentage of Participants with Adverse Events
Measured: Up to 10 weeks
Percentage of Participants with Laboratory, ECGs, Ophthalmological Assessments, And Vital Signs Abnormalities
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start3 Jan 2017
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036501
- Sponsor's protocol ID
- BP39122
- Other IDs
- 2016-003461-26, 2016
- Status last verified
- Oct 2018
- First submitted
- 26 Jan 2017
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No