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

NCT01802853 | Completed Phase 1

• 2 other identifiers: BP284382012-005773-31
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC)

  48 hours

Secondary Outcomes (3)

• Safety: Incidence of adverse events

  approximately 5 weeks

• Pharmacodynamics: Fasting serum glucose/serum insulin

  48 hours

• Nausea scale: Visual analogue scale

  48 hours

Study Arms (2)

A: RO6811135 s.c.

EXPERIMENTAL

Drug: RO6811135

B: RO6811135 i.v.

ACTIVE COMPARATOR

Drug: RO6811135

Interventions

RO6811135 DRUG

Single subcutaneous dose

A: RO6811135 s.c.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Leeds, LS2 9LH, United Kingdom

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 1, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

GB (1)