Clinical Trial Protocol Registry

Trial information

A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

Status:
Completed
Protocol number:
BP25679
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Product name:
RO4995819
Official Scientific 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
Brief summary:
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. Target sample size is 32.
Study phase:
I
Study type:
Interventional; Other; Randomized; Double Blind; Parallel; Safety study
Conditions:
  • Healthy Volunteer
Primary outcome:
  1. Safety: Incidence of adverse events Time frame: up to 58 days
Key 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
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
Gender:
Males or Females
Age limits:
Min: 18 years Max: 65 years
Accepts healthy volunteers:
Yes
Anticipated start date:
May, 2011
Trial registration date:
18.03.2011
Date last updated:
21.10.2014
This trial was conducted at the following locations:
France
  • STRASBOURG

Link to trial result

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