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Trial record 30 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

Study of Drug Combination on Pharmacokinetics in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02175602
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325 on the pharmacokinetics of selective serotonin reuptake inhibitors.

Condition or disease Intervention/treatment Phase
Hepatitis C Infection Drug: Escitalopram Drug: Sertraline Drug: DCV 3DAA FDC Drug: BMS-791325 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of Selective Serotonin Reuptake Inhibitors in Healthy Subjects
Study Start Date : June 2014
Actual Primary Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 2
Sertraline (50 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Sertraline (50 milligrams each morning) days 23-29
Drug: Sertraline
50 milligrams administered each morning
Other Name: Zoloft

Drug: DCV 3DAA FDC
Fixed dose combination (daclatasvir [DCV] 30 milligrams, asunaprevir [ASV] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily

Drug: BMS-791325
75 milligrams single-agent film coated oral tablet administered twice daily

Experimental: Cohort 1
Escitalopram (10 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Escitalopram (10 milligrams each morning) days 23-29
Drug: Escitalopram
10 milligrams administered each morning
Other Name: Lexapro

Drug: DCV 3DAA FDC
Fixed dose combination (daclatasvir [DCV] 30 milligrams, asunaprevir [ASV] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily

Drug: BMS-791325
75 milligrams single-agent film coated oral tablet administered twice daily




Primary Outcome Measures :
  1. Serial blood samples for plasma SSRI (selective serotonin reuptake inhibitor) of escitalopram or sertraline [ Time Frame: Before dosing (0 hour) through 24 hours after SSRI administration on day 7 and day 29 ]
  2. Serial blood samples for determination of plasma concentrations of DCV (daclatasvir), ASV (asunaprevir), BMS-791325, and the metabolite BMS-794712 [ Time Frame: Before dosing (0 hour) through 12 hours after SSRI administration on day 22 and day 29 ]

Secondary Outcome Measures :
  1. Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. [ Time Frame: Two to three months ]


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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed Informed Consent Form

    a) Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.

  2. Target Population

    a) Healthy subjects as determined by no clinically significant deviation from normal in medical history, psychiatric history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results.

  3. Age and Reproductive Status

    1. Males and females, ages 25 to 55 years, inclusive.
    2. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
    3. Women must not be breastfeeding.

Exclusion Criteria:

  1. Any significant acute or chronic medical illness.
  2. Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug (appendectomies with no complications are allowed at the investigator's discretion).
  3. Any major surgery within 4 weeks of study drug administration.
  4. Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration).
  5. Any other sound medical, psychiatric, and/or social reason as determined by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175602


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Principal Investigator: Ikenna Ogbaa, MD PPD

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02175602     History of Changes
Other Study ID Numbers: AI443-116
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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Citalopram
Serotonin Uptake Inhibitors
Dexetimide
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Sertraline
Asunaprevir
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents