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NCT Number: NCT01802853

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO6811135

Drug

Single subcutaneous dose

Primary outcomes

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

    Time frame: 48 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 1, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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