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OpenTrials
Completed

NCT Number: NCT01711801

A Study of Safety, Pharmacokinetics (Including Food Effect) And Pharmacodynamics of RO5545965 in Healthy Volunteers

This randomized, Investigator/Subject-blind, adaptive single-ascending-dose, placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics (including the effect of food), and pharmacodynamics of RO5545965 following oral administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive 2 doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout period of approximately 2 weeks between treatment periods.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Zuidlaren, 9471 GP, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteers, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
  • Body mass index (BMI) 18 to 30 kg/m2 inclusive
  • Male subjects (whether surgically sterilized or not) with female partners of child-bearing potential must use two forms of contraception, one of which must be a barrier method, for the duration of the study and for 77 days after the last dose

Exclusion criteria

  • History or presence of any clinically significant disease or disorder
  • Any condition or disease that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator
  • History of clinically significant hypersensitivity or allergic drug reactions
  • Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
  • Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Dietary restrictions that would prohibit the consumption of standardized meals
  • Participation in an investigational drug or device study within 90 days prior to screening, as calculated from the follow-up from the previous study

Treatment and study plan

Placebo

Drug

Single ascending dose

RO5545965

Drug

Single ascending dose

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: up to approximately 10 weeks

Secondary outcomes

  1. Pharmacokinetics: Area under the concentration-time curve (AUC)

    Time frame: Pre-dose and up to 48 hours post-dose

  2. Pharmacokinetics: Maximum plasma concentration (Cmax)

    Time frame: Pre-dose and up to 48 hours post-dose

  3. Pharmacodynamics: Prolactin levels

    Time frame: Pre-dose and up to 10 hours post-dose

  4. Effect of food on the pharmacokinetics of single dose RO55459965: Area under the concentration-time curve (AUC)

    Time frame: pre-dose and up to 48 hours post-dose

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Single-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics of RO5545965 Following Oral Administration in Healthy Subjects.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2012
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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