- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01159821
A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers
7 april 2014 uppdaterad av: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open-Label Study to Assess the Effect of CYP2D6 Inhibitor Paroxetine on the Single-Dose Pharmacokinetics of JNJ-31001074 in Healthy Subjects
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
14
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Kansas
-
Overland Park, Kansas, Förenta staterna
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
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
Tidsram: 0 to 72 hours after study drug administration on Day 1 and Day 13
|
0 to 72 hours after study drug administration on Day 1 and Day 13
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
The number and type of adverse events and serious adverse events reported
Tidsram: 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
|
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
Tidsram: During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
|
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
Tidsram: During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
|
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
Tidsram: During screening (15 to 29 days before study drug administration) and on Day 16 or at the time of early withdrawal from the study
|
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
Tidsram: During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
|
During screening (15 to 29 days before study drug administration) through Day 16 or at the time of early withdrawal from the study
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2010
Avslutad studie (Faktisk)
1 oktober 2010
Studieregistreringsdatum
Först inskickad
8 juli 2010
Först inskickad som uppfyllde QC-kriterierna
8 juli 2010
Första postat (Uppskatta)
9 juli 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
8 april 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 april 2014
Senast verifierad
1 april 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Läkemedels fysiologiska effekter
- Neurotransmittormedel
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Psykotropa droger
- Serotoninupptagshämmare
- Neurotransmittorupptagshämmare
- Membrantransportmodulatorer
- Serotoninmedel
- Antidepressiva medel
- Cytokrom P-450 enzymhämmare
- Antidepressiva medel, andra generationen
- Cytokrom P-450 CYP2D6-hämmare
- Paroxetin
Andra studie-ID-nummer
- CR017242
- 31001074ATT1014 (Annan identifierare: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Friska
-
University of MiamiJames and Esther King Biomedical Research ProgramAvslutadHealthy Lifetime Icke-rökareFörenta staterna
-
University of LeicesterNational Institute for Health Research, United KingdomAvslutadPatienter med hjärtsvikt och konserverad ejektionsfraktion - HFpEF | Patienter med hjärtsvikt med reducerad ejektionsfraktion - HFrEF | Healthy Controls Group - ålders- och könsmatchad
-
University Hospital, GrenobleUniversity Hospital, Clermont-Ferrand; Grenoble Institut des NeurosciencesAvslutadParkinsons sjukdom | Healthy Controls Group - ålders- och könsmatchadFrankrike
Kliniska prövningar på 31001074/paroxetine
-
Johnson & Johnson Pharmaceutical Research & Development...AvslutadAttention Deficit Hyperactivity Disorder | Attention Deficit Disorders med hyperaktivitet
-
Johnson & Johnson Pharmaceutical Research & Development...AvslutadAttention Deficit Hyperactivity Disorder | Attention Deficit Disorders med hyperaktivitet
-
Johnson & Johnson Pharmaceutical Research & Development...Indragen
-
Johnson & Johnson Pharmaceutical Research & Development...Avslutad
-
Johnson & Johnson Pharmaceutical Research & Development...AvslutadAttention Deficit Hyperactivity DisorderFörenta staterna
-
GlaxoSmithKlineAvslutad
-
GlaxoSmithKlineAvslutadDepressiv sjukdom, major | Major depressiv sjukdom (MDD)Kina
-
Oizumi HospitalOkänd
-
GlaxoSmithKlineAvslutad
-
University of GöttingenGlaxoSmithKlineAvslutad