- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01396005
A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123)
An Open-Label, One-Period Study in Patients Receiving Methadone or Buprenorphine/Naloxone Maintenance Therapy to Evaluate the Effect of SCH 503034 (Boceprevir) on Either Methadone or Buprenorphine/Naloxone Plasma Concentrations (Protocol No. P08123)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Body Mass Index (BMI) between 18 and 36, inclusive
- Reliable participation in a methadone maintenance or buprenorphine maintenance or buprenorphine/naloxone maintenance program for at least two (2) months prior to Day 1.
- Is receiving once daily oral dose of methadone therapy at a stable
individualized dose for at least 4 weeks, receiving once
daily buprenorphine dose at a stable individualized dose for at 4 weeks with, if on buprenorphine only therapy, naloxone added for at least 2 weeks prior to Day 1.
- 12-lead electrocardiogram (ECG) conduction intervals within gender-specific normal range
- Vital signs within normal range
- Clinical laboratory tests within normal range
- Women who are postmenopausal, surgically sterilized, or premenopausal and use a medically-accepted method of contraception.
Exclusion Criteria:
- Pregnancy, breast feeding, or intention to become pregnant or father a child while on study or within 3 months after end of trial
- History or presence of inflammatory bowel disease, ulcers, or gastrointestinal or rectal bleeding
- History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
- History of pancreatic injury or pancreatitis
- History or presence of liver disease or liver injury
- History or presence of impaired renal function
- History of urinary obstruction or difficulty in voiding
- History of any infectious disease within 4 weeks prior to drug administration that in the opinion of the investigator, affects the subject's ability to participate in the trial
- Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
- Positive screen for drugs with a high potential for abuse such as cocaine, amphetamines, methylenedioxymethamphetamine (MDMA), barbiturates, benzodiazepines, or opiates/opioids
Excessive use of alcohol in the 2 weeks prior to Day -1, defined as greater than 3 glasses of alcoholic beverages (1 is approximately equivalent to: beer [284 mL/10 oz], wine
[125 mL/4 oz], or distilled spirits [25 mL/1 oz]) per day.
- Blood donation in the past 60 days
- Previous administration of SCH 503034 (boceprevir)
- Current participation in another clinical study or participation in a clinical study (e.g., laboratory or clinical evaluation) within 30 days of baseline
- Study staff personnel or family members of the study staff personnel
- Demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) that, in the opinion of the investigator and sponsor, interfere with their ability to participate in the trial
- History of malignancy within 5 years from Screening
- Consumption of excessive amounts (equivalent to > 6 cups of brewed coffee/day) of coffee, tea, cola or other caffeinated beverages
- Receipt of any of the following more recently than the washout period prior to Baseline: inhibitors or inducers of cytochrome (CYP) P450, CYP2B6, CYP3A4, and CYP2D6; or oral contraceptives containing drospirenone
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Methadone + boceprevir
Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
|
boceprevir 800 mg (4 x 200 mg capsules), orally, every 8 hours, Day 2 through Day 7
Altri nomi:
methadone, 20-150 mg tablets, liquid, or disket, orally, once per day, Day 1 through Day 8
|
Sperimentale: Buprenorphine/naloxone + boceprevir
Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
|
boceprevir 800 mg (4 x 200 mg capsules), orally, every 8 hours, Day 2 through Day 7
Altri nomi:
buprenorphine/naloxone 8/2-24/6 mg, tablets, sublingual, once per day, Day 1 through Day 8
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Area Under the Concentration Versus Time Curve (AUC) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir
Lasso di tempo: Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
|
AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in).
The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration.
The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration.
The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir.
|
Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
|
Maximum Concentration (Cmax) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir
Lasso di tempo: Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
|
Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in).
The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration.
The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration.
The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir.
|
Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
|
AUC of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir
Lasso di tempo: Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
|
AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in).
The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration.
The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration.
The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.
|
Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
|
Cmax of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir
Lasso di tempo: Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
|
Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in).
The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration.
The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration.
The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.
|
Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
AUC of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir
Lasso di tempo: Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
|
AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in).
The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration.
The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration.
The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.
|
Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
|
Cmax of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir
Lasso di tempo: Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
|
Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in).
The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration.
The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration.
The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.
|
Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie del fegato
- Flaviviridae Infezioni
- Epatite, virale, umana
- Epatite
- Epatite C
- Effetti fisiologici delle droghe
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Analgesici
- Agenti del sistema sensoriale
- Analgesici, oppioidi
- Narcotici
- Antagonisti narcotici
- Agenti del sistema respiratorio
- Agenti antitosse
- Buprenorfina
- Nalossone
- Buprenorfina, combinazione di farmaci naloxone
- Metadone
Altri numeri di identificazione dello studio
- P08123
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Virus dell'epatite C
-
National Institute of Allergy and Infectious Diseases...CompletatoSano | Infezione da virus di Epstein BarrStati Uniti
-
TakedaCompletatoInfezioni da Flavivirus | Partecipanti sani | Virus, Zika | Malattia da virus ZikaStati Uniti, Porto Rico
-
Institute of Tropical Medicine, BelgiumCompletatoTrasmissione | Zik Virus | Malattia da virus Zika | Diffusione di virusBelgio
-
Sun Yat-sen UniversityWuzhou Red Cross Hospital; Zhongshan People's Hospital, Guangdong, ChinaReclutamento
-
AlloVirAttivo, non reclutanteBK Infezione da virus | Infezioni da virus di Epstein-Barr | Infezioni da citomegalovirus | Infezione da adenovirus | Infezione da virus JC | Infezione da virus dell'herpes umano-6Stati Uniti
-
AlloVirTerminatoBK Infezione da virus | Infezioni da virus di Epstein-Barr | Infezioni da citomegalovirus | Infezione da adenovirus | Infezione da virus JC | Infezione da virus dell'herpes umano-6Corea, Repubblica di, Stati Uniti, Spagna, Francia, Tacchino, Australia, Regno Unito, Italia, Canada, Belgio
-
The University of Texas Medical Branch, GalvestonShriners Hospitals for ChildrenCompletatoBrucia | Varicella | Citomegalovirus | Virus dell'herpes simplex | Virus varicella-zoster | Virus dell'herpes umano
-
Universitair Ziekenhuis BrusselReclutamento
-
Merck Sharp & Dohme LLCCompletatoInfezione da virus della varicella
-
Marmara UniversityCompletatoComportamento sanitario | Papilloma-virus umanoTacchino
Prove cliniche su boceprevir
-
Merck Sharp & Dohme LLCCompletato
-
Merck Sharp & Dohme LLCTerminato
-
Indiana UniversityMerck Sharp & Dohme LLCCompletato
-
Erasmus Medical CenterRadboud University Medical Center; University Medical Center Groningen; Maastricht... e altri collaboratoriCompletatoEpatite C | Virus dell'immunodeficienza umanaOlanda
-
Arrowhead Regional Medical CenterTerminatoInfezione da epatite CStati Uniti
-
St Stephens Aids TrustUniversity of Turin, Italy; University of LiverpoolCompletato
-
GlaxoSmithKlineCompletatoTrombocitopeniaStati Uniti
-
Hoffmann-La RocheCompletatoEpatite C, cronicaFrancia, Stati Uniti, Canada, Germania, Spagna, Italia, Porto Rico
-
Merck Sharp & Dohme LLCCompletato