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OpenTrials
Completed

NCT Number: NCT01418963

A Study of RO5285119 in Healthy Volunteers

This two-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each subject.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rennes, France

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male adults, 18 to 45 years of age (Part 1) or healthy male or female adults, 18 to 65 years of age (Part 2)
  • Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
  • Female subjects must be surgically sterile or postmenopausal
  • Male subjects must use a barrier method of contraception for the duration of the study and for the three months after the last dosing

Exclusion criteria

  • History or presence of any significant disease or disorder
  • Positive for hepatitis B. hepatitis C or HIV infection
  • History of drug or alcohol abuse or suspicion of regular consumption of drugs of abuse
  • Participation in an investigational drug or device study within 3 months prior to first dosing
  • Donation of blood within 3 months prior to first dosing
  • Regular smoker (>5 cigarettes, >3 pipe-fulls, >3 cigars per day)
  • History of hypersensitivity or allergic reactions
  • Part 2: Contraindications for MRI scans

Treatment and study plan

RO5285119

Drug

single and multiple ascending oral doses

Placebo

Drug

single and multiple oral doses

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: up to 5 weeks

Secondary outcomes

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

    Time frame: up to 5 weeks

  2. Pharmacodynamics (neurological effects): Profile of Mood States/Bond&Lader VAS/smell test/C-SSRS

    Time frame: up to 5 weeks

  3. Pharmacodynamics: Biomarker levels (ACTH, prolactin, cortisol, vasopressin)

    Time frame: up to 5 weeks

  4. Pharmacodynamics: Functional Magnetic Resonance Imaging

    Time frame: up to 5 weeks

  5. Food effect: Comparison of single dose pharmacokinetics (AUC) in fasted and fed state (Part 1b)

    Time frame: up to 5 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single- and Multiple Ascending-Dose, Randomized, Double-Blind, Placebo-Controlled Study in Two Single-Center Study Parts to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5285119 Following Oral Administration in Healthy Subjects

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 17, 2011
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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