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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01802853

Enrollment

Registered

2013-03-01

Start date

2013-05-31

Completion date

2013-06-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGRO6811135

Single subcutaneous dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026