A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers

NCT01159821 | Completed Phase 1

• 2 other identifiers: CR01724231001074ATT1014
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

31001074; Paroxetine; CYP2D6 inhibitor

Outcome Measures

Primary Outcomes (1)

• 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

  0 to 72 hours after study drug administration on Day 1 and Day 13

Secondary Outcomes (5)

• The number and type of adverse events and serious adverse events reported

  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

• Results from clinical laboratory tests performed

  During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study

• Findings from electrocardiograms (ECGs) and vital signs measurements performed

  During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study

• Findings from physical examinations performed

  During screening (15 to 29 days before study drug administration) and on Day 16 or at the time of early withdrawal from the study

• Columbia Suicide Severity Rating Scale (C-SSRS) scores to assess severity and track suicidal events during treatment

  During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study

Study Arms (1)

001

EXPERIMENTAL

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

Interventions

31001074/paroxetine DRUG

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

001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

Paroxetine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 9, 2010
• Study Start: August 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

US (1)