A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367756
• Other study ID #: BP25679
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2011
• Last updated: November 1, 2016
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Francaise de Securite Sanitaire des produits de Sante
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4995819
multiple oral doses, Days 10-16
• citalopram
multiple oral doses, Days 1-16
• placebo
multiple oral doses, Days 10-16

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		up to 58 days	No
Secondary	Effect of multiple doses of RO4995819 on the pharmacokinetics (Cmax, AUC) of citalopram		17 days	No
Secondary	Effect of genetic variants of drug metabolism on pharmacokinetics (Cmax, AUC) of RO4995819 in combination with citalopram		up to 58 days	No