A Single-center Study to Investigate How Quickly and to What Extent a Radioactive Dose of RO5285119 is Absorbed, Metabolized and Eliminated From the Body of Healthy Male Volunteers

Healthy Volunteer Clinical Trial

Official title:

SINGLE-CENTER, OPEN-LABEL, NON-RANDOMIZED STUDY INVESTIGATING THE EXCRETION BALANCE, PHARMACOKINETICS AND METABOLISM OF A SINGLE ORAL DOSE OF [14C]-LABELED RO5285119 IN HEALTHY MALE SUBJECTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179866
• Other study ID #: BP29279
• Secondary ID: 2014-000277-40
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2014
• Last updated: November 1, 2016
• Start date: June 2014
• Est. completion date: July 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate the absorption, distribution, metabolism and elimination of a single oral dose of radiolabeled [14C]-labeled RO5285119 in healthy male participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 64 Years

Eligibility

Inclusion Criteria:

• Healthy male participants, 35 to 64 years of age, inclusive

• For men with a female partner of child-bearing potential: Agreement to use two methods of contraception, including one barrier method e.g. condom, during the treatment period and for at least 3 months after the last dose of study drug

• Participants who do not intend to donate sperm until at least 3 months after the last dose of the study drug

Exclusion Criteria:

• History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis

• Any personal or familial history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures

• Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first dose administration

• Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to a subject

• History or presence of any clinically relevant ECG abnormalities, cardiovascular or cerebrovascular disease

• History of myopathy or muscle disorder

• History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs

• Any CYP3A inhibitor within 2 weeks or within 5 times the elimination half-life, whichever is longer, prior to dosing

• Any CYP3A inducer within 4 weeks or within 5 times the elimination half-life, whichever is longer, prior to dosing

• Infrequent bowel movements (less than once per 24 hours on average)

• Regular work with ionizing radiation or radioactive material

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO5285119
Single oral dose of RO5285119 with approximately 2.1 MBq (56.6 uCi) [14C]-radiolabeled RO5285119 administered as a drinking solution under fasted conditions on Day -1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total recovery of radioactivity over time in urine and feces expressed as a percentage of the total radioactive dose administered		Up to Day 17	No
Primary	Pharmacokinetic profile of total drug-related material, RO5285119 and its metabolites, as appropriate in plasma, estimated Cmax		Up to Day 17	No
Secondary	Percent of dose recovered as total radioactivity, i.e. relative abundance of RO5285119 and its metabolite(s) in plasma, urine and feces		Up to Day 17	No
Secondary	Incidence of adverse events		Up to 28 days after the last dose of study drug	No