Completed

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.

What is being tested

RO6811135

+ RO6811135

Drug

Who is being recruted

From 18 to 45 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Phase 1

Interventional

Study Start: May 2013

See protocol details

Summary

Principal SponsorHoffmann-La Roche

Last updated: November 2, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01802853

Principal SponsorHoffmann-La Roche

Last updated: November 2, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate

Body mass index (BMI) between 18-30 kg/m2

Healthy as determined by screening assessments

Male healthy volunteers, 18-45 years of age inclusive

7 exclusion criteria prevent from participating

Any clinically relevant abnormal test results prior to first dosing

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

Any history of alcohol and/or drug of abuse addiction during the past 5 years

History of anaphylaxis or severe systemic hypersensitivity or allergic reactions

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Leeds, United KingdomOpen in Google Maps

CompletedOne Study Center