A Study of RO4995819 in Combination With Citalopram in Healthy Volunteers

NCT01367756 | Completed Phase 1

• 1 other identifier: BP25679
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of adverse events

  up to 58 days

Secondary Outcomes (2)

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

  17 days

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

  up to 58 days

Study Arms (2)

1

EXPERIMENTAL

Drug: RO4995819; Drug: citalopram

2

PLACEBO COMPARATOR

Drug: citalopram; Drug: placebo

Interventions

RO4995819 DRUG

multiple oral doses, Days 10-16

1

citalopram DRUG

multiple oral doses, Days 1-16

1; 2

placebo DRUG

multiple oral doses, Days 10-16

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Strasbourg, 67064, France

Location

MeSH Terms

Interventions

Citalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 7, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (1)