A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT01367756
• Date of registration: 30/05/2011
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers
• 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
• Date of first enrolment: May 2011
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01367756
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteer

Intervention(s)

Drug: placebo

Drug: RO4995819

Drug: citalopram

Primary Outcome(s)

Safety: Incidence of adverse events [Time Frame: up to 58 days]

Secondary Outcome(s)

Effect of multiple doses of RO4995819 on the pharmacokinetics (Cmax, AUC) of citalopram [Time Frame: 17 days]

Effect of genetic variants of drug metabolism on pharmacokinetics (Cmax, AUC) of RO4995819 in combination with citalopram [Time Frame: up to 58 days]

Secondary ID(s)

BP25679

Source(s) of Monetary Support

Please refer to primary and secondary sponsors