Study Evaluating a Combined Administration of Lecozotan SR and Citalopram in Young Healthy Subjects
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00538889
First received: October 1, 2007
Last updated: December 9, 2007
Last verified: December 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To assess the safety and tolerability of lecozotan SR and citalopram when coadministred to healthy subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Lecozotan SR Drug: Citalopram |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Combined Administration of Lecozotan SR and Citalopram: a Double Blind, Multiple Dose Study in Young Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Signed and dated IRB/IEC-approved informed consent form before any study-specific screening procedures are performed.
- Men or women aged 18 to 50 years, inclusive, at screening.
- Women of nonchildbearing potential, defined as being surgically sterile or postmenopausal for > 1 year, may be included. For women below 50 years of age, at least two years of retrospective amenorrhea and FSH>38 and estrogen <20 are required.
- Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's average height, in meters, at screening: BMI = weight (kg)/(height [m])2
Exclusion Criteria:
- Presence or history of any disorder that may prevent the successful completion of the study.
- Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results.
- Hypersensitivity to citalopram or any of the inactive ingredients in citalopram.
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00538889 History of Changes |
| Other Study ID Numbers: | 3098B1-134 |
| Study First Received: | October 1, 2007 |
| Last Updated: | December 9, 2007 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Adult |
Additional relevant MeSH terms:
|
Citalopram Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |
ClinicalTrials.gov processed this record on May 19, 2013