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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01802853
First received: February 28, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Healthy Volunteer
Drug: RO6811135
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 5 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Fasting serum glucose/serum insulin [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Nausea scale: Visual analogue scale [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: RO6811135 s.c. Drug: RO6811135
Single subcutaneous dose
Active Comparator: B: RO6811135 i.v. Drug: RO6811135
Single intravenous dose

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802853

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01802853     History of Changes
Other Study ID Numbers: BP28438, 2012-005773-31
Study First Received: February 28, 2013
Last Updated: August 4, 2014
Health Authority: United Kingdom: Department of Health

ClinicalTrials.gov processed this record on August 20, 2014