A Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled Risdiplam (RO7034067) in Healthy Male Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03036501
• Date of registration: 26/01/2017
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled Risdiplam (RO7034067) in Healthy Male Participants
• Scientific title: Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled RO7034067 in Healthy Male Subjects
• Date of first enrolment: January 3, 2017
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03036501
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Netherlands

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 35 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: [^14C]-Risdiplam

Primary Outcome(s)

Percentage of Dose Recovered as Total [14C]-radioactivity in Urine [Time Frame: Day 1 to Day 36]

Time to Maximum Observed Plasma Concentration of Risdiplam (Tmax) [Time Frame: Day 1 to Day 36]

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]

Cumulative Urinary Amount of Total [14C]-Radioactivity in Urine [Time Frame: Day 1 to Day 36]

Percentage of Dose Recovered as Total [14C]-radioactivity in Feces [Time Frame: Day 1 to Day 36]

Area Under Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) [Time Frame: Day 1 to Day 36]

Apparent Terminal Elimination Half-Life (t1/2) [Time Frame: Day 1 to Day 36]

Maximum Observed Plasma Concentration (Cmax) of Risdiplam [Time Frame: Day 1 to Day 36]

Secondary Outcome(s)

Percentage of Participants with Adverse Events [Time Frame: Up to 10 weeks]

Percentage of Participants with Laboratory, ECGs, Ophthalmological Assessments, And Vital Signs Abnormalities [Time Frame: Up to 10 weeks]

Secondary ID(s)

2016-003461-26

BP39122

Source(s) of Monetary Support

Please refer to primary and secondary sponsors