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

Healthy Volunteer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802853
• Other study ID #: BP28438
• Secondary ID: 2012-005773-31
• Status: Completed
• Phase: Phase 1
• First received: February 28, 2013
• Last updated: November 1, 2016
• Start date: May 2013
• Est. completion date: June 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO6811135
Single subcutaneous dose
• RO6811135
Single intravenous dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute bioavailability of RO6811135 after subcutaneous administration: Area under the concentration-time curve (AUC)		48 hours	No
Secondary	Safety: Incidence of adverse events		approximately 5 weeks	No
Secondary	Pharmacodynamics: Fasting serum glucose/serum insulin		48 hours	No
Secondary	Nausea scale: Visual analogue scale		48 hours	No