Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers

NCT03596632 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: GP40605
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Percentage of the Total Radioactive Dose Administered Excreted from Urine and Feces"; TimeFrame: "Day 1 to end of study (approximately 35 days post-dose)

  An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any AE that can be fatal, life threatening, prolongs inpatient hospitalization, significant disability, congenital anamoly, is a significant medical event in the Investigator's judgment.

  Screening to end of study (approximately 35 days post-dose)

Secondary Outcomes (10)

• Maximum Observed Concentration (Cmax) of Fenebrutinib and its Metabolites

  Day 1 pre-dose to end of study (approximately 35 days post-dose)

• Time to Observed Maximum Concentration (Tmax) of Fenebrutinib and its Metabolites

  Day 1 pre-dose to end of study (approximately 35 days post-dose)

• Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) of Fenebrutinib and its Metabolites

  Day 1 pre-dose to end of study (approximately 35 days post-dose)

• Area under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) of Fenebrutinib and its Metabolites

  Day 1 pre-dose to end of study (approximately 35 days post-dose)

• Cumulative Percent of Total Radioactivity Excreted in Urine Over the Sampling Interval (Total % Feu)

  Day 1 pre-dose to end of study (approximately 35 days post-dose)

Study Arms (1)

Single Oral Solution Dose

EXPERIMENTAL

Single 200-mg (approximately 100-µCi) oral solution dose of \[14C/12C\]-fenebrutinib under fasted conditions.

Drug: Fenebrutinib

Interventions

Fenebrutinib DRUG

200-mg (100 µCi) oral solution 14C/12C\]-fenebrutinib

Also known as: RO7010939

Single Oral Solution Dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects, between 18 and 60 years of age, inclusive
• Within body mass index range 18 to 32 kg/m2, inclusive
• In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs, and physical examination
• For males who are sterile: agreement to use a condom with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion; for males who are fertile: agreement to use a condom with spermicide with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion

You may not qualify if:

• History or symptoms of any significant disease
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
• History of stomach or intestinal surgery or resection, except appendectomy, hernia repair, and cholecystectomy
• History of malignancy, except for non-melanoma skin carcinoma with 3-year disease-free follow-up
• Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Day -1
• Exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1
• Participation in a radiolabeled drug study in which exposures are known to the Investigator within 4 months prior to Day -1, or participation in a radiolabeled drug study in which exposures are not known to the Investigator within 6 months prior to Day -1. The total 12-month exposure from this study and a maximum of 2 other studies must be within the Code of Federal Regulations (CFR) recommended levels considered state (per 21 CFR 361.1), e.g. less than 5,000 mrem whole body annual exposure

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Covance Clinical Research Unit, Inc

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

fenebrutinib

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 24, 2018
• Study Start: July 27, 2018
• Primary Completion: August 23, 2018
• Study Completion: August 23, 2018
• Last Updated: December 6, 2018

Record last verified: 2018-12

Locations

US (1)