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A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01159821
First received: July 8, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine the concentration of 31001074 in blood samples from healthy volunteers who have been administered 31001074 and paroxetine.


Condition Intervention Phase
Healthy
Drug: 31001074/paroxetine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-Label Study to Assess the Effect of CYP2D6 Inhibitor Paroxetine on the Single-Dose Pharmacokinetics of JNJ-31001074 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Pharmacokinetic parameters (area under the plasma concentration-time curve [AUC] and the maximum plasma concentration [Cmax]) of 31001074 with and without the coadministration of paroxetine [ Time Frame: 0 to 72 hours after study drug administration on Day 1 and Day 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number and type of adverse events and serious adverse events reported [ Time Frame: From screening (up to 29 days before study drug administration) through 30 days after Day 16 (study completion) or at the time of early withdrawal from the study ] [ Designated as safety issue: No ]
  • Results from clinical laboratory tests performed [ Time Frame: During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study ] [ Designated as safety issue: No ]
  • Findings from electrocardiograms (ECGs) and vital signs measurements performed [ Time Frame: During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study ] [ Designated as safety issue: No ]
  • Findings from physical examinations performed [ Time Frame: During screening (15 to 29 days before study drug administration) and on Day 16 or at the time of early withdrawal from the study ] [ Designated as safety issue: No ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) scores to assess severity and track suicidal events during treatment [ Time Frame: During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: August 2010
Study Completion Date: October 2010
Arms Assigned Interventions
Experimental: 001
31001074/paroxetine 1 tablet of 31001074 will be administered on Day 1 and Day 13. One 20-mg paroxetine tablet will be administered once daily from Days 4 through 15
Drug: 31001074/paroxetine
1 tablet of 31001074 will be administered on Day 1 and Day 13. One 20-mg paroxetine tablet will be administered once daily from Days 4 through 15

Detailed Description:

This is an open-label (both volunteer and study physician will know the identity of study treatment) pharmacokinetic study to determine the effects, if any that multiple 20-mg doses of paroxetine have on the concentration of a single dose of study drug (referred to as 31001074) in the bloodstream after paroxetine and 31001074 are administered orally (by mouth) to healthy adult volunteers. Paroxetine is an approved drug used to treat patients with psychiatric disorders and 31001074 is a drug that is currently under development for potential uses in the treatment of patients with nervous system disorders. Approximately 14 healthy volunteers will participate in the study for approximately 45 days (includes a screening period of up to 29 days to determine eligibility and a 16 day treatment period). Volunteers will be required to stay overnight at the study center during the 16-day treatment period. During the 16-day treatment period, volunteers will receive 2 doses of 31001074 and 12 doses of paroxetine. At Screening, a blood sample will be collected from all volunteers for pharmacogenomic analysis (ie, genetic testing) to identify volunteers genetically-determined to have high activity of an enzyme (CYP2D6) that is involved in the processing of 31001074 by the body. Additional blood samples will be obtained from volunteers at protocol-specified time points during the study to determine the concentration of 31001074 and paroxetine in plasma (the colorless portion of blood). Safety will be evaluated during the study by monitoring adverse events (side effects) reported and findings from clinical laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations performed. In addition, volunteers will be instructed to report the occurrence of adverse events that are considered by the study physician to be serious (as defined by the protocol) for up to 30 days after the administration of the last dose of study drug. A single dose of 31001074 will be administered on Day 1 and Day 13 (total 2 doses). Paroxetine will be administered once daily from Days 4 through 15 (total 12 doses). All doses, including 31001074 and paroxetine will be administered at the same time (approximately 8 am), except on Day 13, when paroxetine will be administered 30 minutes (approximately 7:30 am) before the administration of 31001074.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a body mass index (BMI) (weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
  • Have a blood pressure after the healthy volunteer is supine [ie, lying down face up] for 5 minutes between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at screening and at admission to the study center on Day -1
  • If a woman, must be of nonchildbearing potential, i.e., postmenopausal (no spontaneous menses for at least 2 years) or surgically sterile
  • Be a nonsmoker

Exclusion Criteria:

  • Have a history of or a current medical illness that the investigator (study physician) considers to be clinically significant, a history of chronic uveitis (inflammation of the eye persisting for a long time) or any any intraocular surgery (except for cataract extraction, laser in situ keratomileusis [LASIK], or photorefractive keratectomy [PRK] procedures [ie, procedures used to reshape the cornea of the eye])
  • Have clinically significant abnormal laboratory values, abnormal ECG, or a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
  • If a woman, be pregnant, lactating or completed last term pregnancy within 6 months before admission to study center on Day -1
  • Have known allergy to heparin (agent used to prevent clotting of the blood) or history of heparin induced thrombocytopenia (low blood platelet count as a result of the medication heparin)
  • Have intermediate or low activity of CYP2D6 as determined by genetic testing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159821

Locations
United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01159821     History of Changes
Other Study ID Numbers: CR017242, 31001074ATT1014
Study First Received: July 8, 2010
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
31001074
Paroxetine
CYP2D6 inhibitor

Additional relevant MeSH terms:
Paroxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014