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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01802853
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO6811135 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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.
Study Start Date : May 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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

Primary Outcome Measures :
  1. Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC) [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 5 weeks ]
  2. Pharmacodynamics: Fasting serum glucose/serum insulin [ Time Frame: 48 hours ]
  3. Nausea scale: Visual analogue scale [ Time Frame: 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01802853

United Kingdom
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01802853     History of Changes
Other Study ID Numbers: BP28438
2012-005773-31 ( EudraCT Number )
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016