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

Open Label, Randomized, 2 Way-crossover Study to Investigate the Absolute Bioavailability and Pharmacokinetics of RO6811135, Following Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Subjects.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO6811135; Drug: RO6811135

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: RO6811135 s.c.	Drug: RO6811135; Single subcutaneous dose; Drug: RO6811135; Single intravenous dose
Active Comparator: B: RO6811135 i.v.	Drug: RO6811135; Single subcutaneous dose; Drug: RO6811135; Single intravenous dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: February 28, 2013
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BP28438; 2012-005773-31 (EudraCT Number)