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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: [^14C]-Risdiplam

Study type

Interventional

Funder types

Industry

Identifiers

NCT03036501

2016-003461-26 (EudraCT Number)

BP39122

Details and patient eligibility

About

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).

Enrollment

6 patients

Sex

Male

Ages

35 to 65 years old

Volunteers

Accepts Healthy Volunteers

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