A Bioavailability and Pharmacokinetic Study of Subcutaneous and Intravenous RO6811135 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO6811135

• Registration Number: NCT01802853
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This open-label, randomized, 2-way crossover study will assess the absolute bioavailability and pharmacokinetics of RO6811135 in healthy male volunteers. Subjects will be randomized to one of the sequences AB or BA to receive single doses of subcutaneous (A) or intravenous (B) RO6811135, with a washout period of at least 7 days between dosing.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-01
• Study Start: 2013-05
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Male healthy volunteers, 18-45 years of age inclusive
• Healthy as determined by screening assessments
• Body mass index (BMI) between 18-30 kg/m2

Exclusion Criteria

• Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological or connective tissue disease or diseases
• History of anaphylaxis or severe systemic hypersensitivity or allergic reactions
• Any history of alcohol and/or drug of abuse addiction during the past 5 years
• Smoking more than 5 cigarettes a day or the equivalent amount of tobacco
• Any clinically relevant abnormal test results prior to first dosing
• Positive for hepatitis B, hepatitis C or HIV infection
• Participation in an investigational drug or device study within 3 months prior to Day -1 of Period 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B: RO6811135 i.v.	RO6811135	-
A: RO6811135 s.c.	RO6811135	-

Primary Outcome Measures

Name	Time	Method
Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC)	48 hours

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	approximately 5 weeks
Pharmacodynamics: Fasting serum glucose/serum insulin	48 hours
Nausea scale: Visual analogue scale	48 hours