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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03036501
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE January 26, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date October 4, 2018
Actual Study Start Date  ICMJE January 3, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
  • Percentage of Dose Recovered as Total [14C]-radioactivity in Urine [ 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 ]
  • Maximum Observed Plasma Concentration (Cmax) of Risdiplam [ 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Percentage of Dose Recovered as Total [14C]-radioactivity in Urine [ 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 ]
  • Maximum Observed Plasma Concentration (Cmax) of RO7034067 [ Time Frame: Day 1 to Day 36 ]
  • Time to Maximum Observed Plasma Concentration of RO7034067 (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 ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled Risdiplam (RO7034067) in Healthy Male Participants
Official Title  ICMJE Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Oral Dose of [14C]-Labeled RO7034067 in Healthy Male Subjects
Brief 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. 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: [^14C]-Risdiplam
[^14C]-Risdiplam 18 mg oral solution with approximately 0.75 megabecquerel MBq (20 microcuries [μCi]) of [14C]-labeled Risdiplam.
Study Arms  ICMJE Experimental: [^14C]-Risdiplam
Participants will be administered with [^14C]-Risdiplam solution orally under fasted conditions on Day 1.
Intervention: Drug: [^14C]-Risdiplam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2017)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03036501
Other Study ID Numbers  ICMJE BP39122
2016-003461-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP