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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: RO6811135

Study type: Interventional

Funder types: Industry

Identifiers

NCT01802853

BP28438

2012-005773-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

12 participants in 2 patient groups

A: RO6811135 s.c.

Experimental group

Treatment:

Drug: RO6811135

Drug: RO6811135

B: RO6811135 i.v.

Active Comparator group

Treatment:

Drug: RO6811135

Drug: RO6811135