- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02681198
Lofexidine Pharmacokinetics in the Presence of Paroxetine in Healthy Volunteers
22. februar 2018 opdateret af: USWM, LLC (dba US WorldMeds)
Lofexidine Pharmacokinetics in the Presence of Paroxetine, a Strong CYP2D6 Inhibitor, in Healthy Volunteers
The purpose of this study is to determine the pharmacokinetics, safety and tolerability of lofexidine HCl in the presence of paroxetine in healthy adults.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a Phase 1, open-label, single-sequence study to determine the pharmacokinetics, safety and tolerability of lofexidine HCl in the presence of paroxetine in healthy adults.
Lofexidine HCl is an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.
Paroxetine HCl is an orally administered psychotropic drug indicated in the treatment of major depressive, obsessive compulsive, panic, social anxiety, and generalized anxiety disorders.
Paroxetine is a strong CYP2D6 inhibitor.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
-
San Antonio, Texas, Forenede Stater, 78217
- Worldwide Clinical Trials
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subject is between ages of 18 to 60 years at enrollment with a body mass index (BMI) between 18 and 35 kg/m2.
- Female subjects must not be lactating, and must either a) be postmenopausal or b) agree to use an acceptable form of birth control from screening until 14 days after completion of the study.
- Subject is in good health based on medical history, physical exam, laboratory profile, and electrocardiogram (ECG) as judged by the Investigator.
- If subject smokes, subject agrees to limit smoking while in the study to not more than 10 cigarettes per day.
Exclusion Criteria:
- History of suicidal ideations or depression requiring professional intervention including counseling or antidepressant medication over the past 12 months.
- History or presence of allergic or adverse response to lofexidine, paroxetine, or related drugs.
- Received any drugs capable of inhibiting CYP enzymes CYP1A2, CYP2C19, or CYP2D6 within 14 days or 5 half-lives (whichever is more) before Day 1.
- Consumes more than 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) or has a significant history of alcohol abuse or drug/chemical abuse within the last 1 year.
- Has a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Lofexidine and paroxetine
Lofexidine in the presence of paroxetine
|
All subjects will receive two single doses of lofexidine HCl; one 0.4 mg dose taken alone on Day 1 and one 0.4 mg dose taken with 40 mg once daily paroxetine HCl at steady-state on Day 13.
All subjects will receive daily single doses of paroxetine HCl; one 20 mg dose taken Days 4-6, one 40 mg dose taken Days 7-19, one 20 mg dose taken Day 20, one 10 mg dose taken Days 21-22.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maximum Plasma Concentration (Cmax)
Tidsramme: 0 hour (predose) and 0.25, 0.5, 1, 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48 and 72 hours after lofexidine Dose 1; 0 hour (predose) and 0.25, 0.5, 1 , 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48, 72, 96, 120, 144 and 168 hours after lofexidine Dose 2.
|
0 hour (predose) and 0.25, 0.5, 1, 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48 and 72 hours after lofexidine Dose 1; 0 hour (predose) and 0.25, 0.5, 1 , 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48, 72, 96, 120, 144 and 168 hours after lofexidine Dose 2.
|
Time to Maximum Plasma Concentration (Tmax)
Tidsramme: 0 hour (predose) and 0.25, 0.5, 1, 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48 and 72 hours after lofexidine Dose 1; 0 hour (predose) and 0.25, 0.5, 1 , 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48, 72, 96, 120, 144 and 168 hours after lofexidine Dose 2.
|
0 hour (predose) and 0.25, 0.5, 1, 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48 and 72 hours after lofexidine Dose 1; 0 hour (predose) and 0.25, 0.5, 1 , 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48, 72, 96, 120, 144 and 168 hours after lofexidine Dose 2.
|
Apparent Terminal Elimination Half-life (T½)
Tidsramme: 0 hour (predose) and 0.25, 0.5, 1, 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48 and 72 hours after lofexidine Dose 1; 0 hour (predose) and 0.25, 0.5, 1 , 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48, 72, 96, 120, 144 and 168 hours after lofexidine Dose 2.
|
0 hour (predose) and 0.25, 0.5, 1, 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48 and 72 hours after lofexidine Dose 1; 0 hour (predose) and 0.25, 0.5, 1 , 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48, 72, 96, 120, 144 and 168 hours after lofexidine Dose 2.
|
Area Under the Concentration-Time Curve from Time Zero to Last Quantified Concentration (AUC 0-t)
Tidsramme: 0 hour (predose) and 0.25, 0.5, 1, 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48 and 72 hours after lofexidine Dose 1; 0 hour (predose) and 0.25, 0.5, 1 , 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48, 72, 96, 120, 144 and 168 hours after lofexidine Dose 2.
|
0 hour (predose) and 0.25, 0.5, 1, 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48 and 72 hours after lofexidine Dose 1; 0 hour (predose) and 0.25, 0.5, 1 , 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48, 72, 96, 120, 144 and 168 hours after lofexidine Dose 2.
|
Area Under the Curve from Time Zero to Infinity (AUC 0-infinity)
Tidsramme: 0 hour (predose) and 0.25, 0.5, 1, 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48 and 72 hours after lofexidine Dose 1; 0 hour (predose) and 0.25, 0.5, 1 , 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48, 72, 96, 120, 144 and 168 hours after lofexidine Dose 2.
|
0 hour (predose) and 0.25, 0.5, 1, 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48 and 72 hours after lofexidine Dose 1; 0 hour (predose) and 0.25, 0.5, 1 , 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48, 72, 96, 120, 144 and 168 hours after lofexidine Dose 2.
|
Apparent Clearance (CL/F)
Tidsramme: 0 hour (predose) and 0.25, 0.5, 1, 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48 and 72 hours after lofexidine Dose 1; 0 hour (predose) and 0.25, 0.5, 1 , 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48, 72, 96, 120, 144 and 168 hours after lofexidine Dose 2.
|
0 hour (predose) and 0.25, 0.5, 1, 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48 and 72 hours after lofexidine Dose 1; 0 hour (predose) and 0.25, 0.5, 1 , 2, 3, 4, 5, 6.5, 8, 12, 16, 24, 32, 48, 72, 96, 120, 144 and 168 hours after lofexidine Dose 2.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Blood pressure (sitting and standing)
Tidsramme: screening; predose and 3.5 and 7.5 hours postdose on Days 1, 13; Day 22.
|
screening; predose and 3.5 and 7.5 hours postdose on Days 1, 13; Day 22.
|
|
Heart rate (sitting and standing)
Tidsramme: screening; predose and 3.5 and 7.5 hours postdose on Days 1 and 13; Day 22.
|
screening; predose and 3.5 and 7.5 hours postdose on Days 1 and 13; Day 22.
|
|
Laboratory Assessments
Tidsramme: screening; Day -1, 2, 12, 14; Day 22.
|
Measurements in hematology, blood chemistry, coagulation, and urinalysis parameters will be examined.
Labs will be done at screening, and at Days -1, 2,12,14, 22.
|
screening; Day -1, 2, 12, 14; Day 22.
|
12-lead ECGs
Tidsramme: screening; 0 and 6.5 hours postdose on Days 1, 12, 13; Day 22.
|
screening; 0 and 6.5 hours postdose on Days 1, 12, 13; Day 22.
|
|
Holter ECGs
Tidsramme: 0 (predose), and 3, 4 and 8 hours postdose on Days 1, 12, 13
|
0 (predose), and 3, 4 and 8 hours postdose on Days 1, 12, 13
|
|
Columbia Suicide Severity Rating Scale (C-SSRS)
Tidsramme: screening; Days 7, 13, 22, 50.
|
screening; Days 7, 13, 22, 50.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: George J Atiee, MD, Worldwide Clinical Trials
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2016
Primær færdiggørelse (Faktiske)
1. marts 2016
Studieafslutning (Faktiske)
1. marts 2016
Datoer for studieregistrering
Først indsendt
1. februar 2016
Først indsendt, der opfyldte QC-kriterier
9. februar 2016
Først opslået (Skøn)
12. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. februar 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Lægemidlers fysiologiske virkninger
- Adrenerge midler
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Antihypertensive midler
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Sensoriske systemagenter
- Adrenerge alfa-2-receptoragonister
- Adrenerge alfa-agonister
- Adrenerge agonister
- Psykotropiske stoffer
- Serotoninoptagelseshæmmere
- Neurotransmitter optagelseshæmmere
- Membrantransportmodulatorer
- Serotoninmidler
- Antidepressive midler
- Narkotiske antagonister
- Cytokrom P-450 enzymhæmmere
- Antidepressive midler, anden generation
- Cytokrom P-450 CYP2D6-hæmmere
- Paroxetin
- Lofexidin
Andre undersøgelses-id-numre
- USWM-LX1-1010
- U01DA033276 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Lofexidine
-
USWM, LLC (dba US WorldMeds)National Institute on Drug Abuse (NIDA)Afsluttet
-
USWM, LLC (dba US WorldMeds)National Institute on Drug Abuse (NIDA)AfsluttetOpioidafhængighed | Buprenorphin AbstinenssyndromForenede Stater
-
USWM, LLC (dba US WorldMeds)National Institute on Drug Abuse (NIDA)AfsluttetOpioidafhængighed | Metadon AbstinenssyndromForenede Stater
-
USWM, LLC (dba US WorldMeds)National Institute on Drug Abuse (NIDA)Afsluttet
-
USWM, LLC (dba US WorldMeds)National Institute on Drug Abuse (NIDA)Afsluttet
-
Mayo ClinicUSWM, LLC (dba US WorldMeds)AfsluttetOpioidtilbagetrækningForenede Stater
-
USWM, LLC (dba US WorldMeds)National Institute on Drug Abuse (NIDA)AfsluttetPersoner med nedsat nyrefunktionForenede Stater
-
New York State Psychiatric InstituteUSWM, LLC (dba US WorldMeds)AfsluttetOpioidbrugsforstyrrelseForenede Stater
-
USWM, LLC (dba US WorldMeds)National Institute on Drug Abuse (NIDA)AfsluttetOpioidafhængighed | Metadon AbstinenssyndromForenede Stater
-
USWM, LLC (dba US WorldMeds)National Institute on Drug Abuse (NIDA)AfsluttetLeversvigtForenede Stater