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Completed

NCT Number: NCT01367756

A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

This randomized, double-blind, parallel-arm study will assess the safety and tolerability of RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.

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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

Strasbourg, 67064, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult healthy male or female subjects, 18 to 65 years of age inclusive (healthy status defined as absence of evidence of any active or chronic disease)
  • Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive
  • Female subjects who are not either surgically sterile or post-menopausal must commit to using a barrier form of contraception in addition to either an intrauterine device or hormonal contraception until at least 5 months after the last dose of study drug
  • Male subjects must use a barrier method of contraception throughout the study and for up to 5 months after the last dose of study drug (applies also to surgically sterilized males)
  • Willing not to participate in any other clinical trial with an investigational drug for at least 5 months following the last dose of study drug

Exclusion criteria

  • Pregnant or lactating females
  • Suspicion of regular consumption of drug of abuse or positive test for alcohol on Day -2
  • Hepatitis B, hepatitis C or HIV infection
  • Smokers of >5 cigarettes or equivalent tobacco intake per day
  • Any confirmed allergic reaction against any drug, or multiple allergies (non-active hay fever is acceptable)
  • Participation in an investigational drug or device study within 3 months prior to dosing

Treatment and study plan

RO4995819

Drug

multiple oral doses, Days 10-16

Citalopram

Drug

multiple oral doses, Days 1-16

Placebo

Drug

multiple oral doses, Days 10-16

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: up to 58 days

Secondary outcomes

  1. Effect of multiple doses of RO4995819 on the pharmacokinetics (Cmax, AUC) of citalopram

    Time frame: 17 days

  2. Effect of genetic variants of drug metabolism on pharmacokinetics (Cmax, AUC) of RO4995819 in combination with citalopram

    Time frame: up to 58 days

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single Center, Randomized, Double-blind, Parallel-design Study to Investigate the Safety and Tolerability of RO4995819 in Combination With Citalopram Following Oral Administration in Healthy Volunteers

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 7, 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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