- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02253836
Pharmacokinetic Study in Healthy Adult Volunteers to Assess the Interactions Between Steady-State Tipranavir and Atazanavir in the Presence of Ritonavir
A Single-Centre Open-Label Study in Healthy Adult Volunteers to Assess the Pharmacokinetic Interactions Between Steady-State TPV (500 mg) and Single-Dose and Steady-State Atazanavir (300 mg QD) in the Presence of Ritonavir (100 mg)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Male and female subjects between 18 and 60 years of age inclusive
- A Body Mass Index (BMI) between 18 and 29 kg/m2
- Signed informed consent prior to trial participation
- Ability to swallow multiple large capsules without difficulty
Acceptable laboratory values that indicate adequate baseline organ function at screening visit:
- Laboratory values are considered to be acceptable if the severity of any parameter is ≤ Grade 1, based on the Division of AIDS/AIDS Clinical Trials Group Grading Scale
- All abnormal laboratory values > Grade 1 are subject to approval by the trial clinical monitor
- Acceptable medical history, physical examination, and 12-lead ECG at screening
Willingness to abstain from the following starting 2 weeks prior to administration of any study medication and up until the end of the study:
- Grapefruit or grapefruit juice, Red wine, Seville oranges, St. John's Wort, and Milk Thistle
- Willingness to abstain from alcohol starting 3 days prior to administration of any study medication up to the end of the study
Willingness to abstain from the following starting 3 days prior to pharmacokinetic (PK) sampling:
- Garlic supplements and Methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.)
- Willingness to abstain from over-the-counter herbal medications for the duration of the study
- Must be a non-smoker
- Willingness to abstain from vigorous physical exercise during intensive PK Days 1, 9, 23, 24 and 32
- Reasonable probability for completion of the study
Exclusion Criteria:
Female subjects of reproductive potential who:
- Have positive serum pregnancy test
- Have not been using a barrier method of contraception for at least 3 months prior to participation in the study
- Are not willing to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and 60 days after completion/termination of the trial
- Are breast-feeding
- Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study
- Use of any medication listed in the protocol within 30 days prior to Day 0 of this study
- Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to Day 0 and for the duration of the study. Due to long half-life,subjects using of Depo-Provera within six months prior to Day 0 will be excluded from participation in this study
- Use of hormone replacement therapy within 1 month prior to Day 0 and anytime during the study
- Administration of antibiotics within 15 days prior to Day 0 and anytime during the study
History of acute illness within 60 days prior to Day 0
o Subjects will be excluded for acute illnesses that occurred more than 60 days prior to Day 0 if, in the opinion of the investigator, the subject does not qualify as a healthy volunteer
- Have serological evidence of hepatitis B or C virus
- Have serological evidence of exposure to HIV
- Alcohol or substance abuse within 1 year prior to screening or during the study
- Blood or plasma donations within 30 days prior to Day 0 or during the study
- Subjects with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering Tipranavir, Ritonavir or Atazanavir to the subject
- Subjects with pre-existing heart conduction abnormalities
- Subjects who have taken (within 7 days prior to Day 0) any over-the-counter or prescription medication that, in the opinion of the investigator in consultation with the clinical monitor, might interfere with absorption, distribution, or metabolism of the study medications
- Known hypersensitivity to sulphonamide class of drugs
- Inability to adhere to the protocol
- Cautions or warnings in the Ritonavir and Atazanavir package insert which, in the opinion of the investigator, constitute grounds for subject exclusion
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: TAZ/RTV - TPV/RTV - TPV/RTV+TAZ
Days 1-9: single dose TAZ/RTV Days 16-23: morning and evening dose TPV/RTV Days 24-32: TPV/RTV + TAZ |
TPV
RTV
TAZ
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Maximum plasma concentration
Délai: up to day 33
|
up to day 33
|
Drug concentration in plasma at 12 hr after administration for Tipranavir (TPV) and Ritonavir (RTV)
Délai: 12 hours after drug administration
|
12 hours after drug administration
|
Drug concentration in plasma at 24 hr after administration for Atazanavir (TAZ)
Délai: 24 hours after drug administration
|
24 hours after drug administration
|
Area under plasma concentration time curve from 0-12 hours (AUC0-12h) for TPV and RTV
Délai: up to 12 hours after drug administration
|
up to 12 hours after drug administration
|
AUC0-24h for TAZ
Délai: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Time from dosing to the maximum concentration
Délai: up to day 33
|
up to day 33
|
Elimination half-life
Délai: up to day 33
|
up to day 33
|
Oral clearance
Délai: up to day 33
|
up to day 33
|
Volume of distribution
Délai: up to day 33
|
up to day 33
|
Number of patients with adverse events
Délai: up to day 33
|
up to day 33
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Inhibiteurs d'enzymes
- Agents anti-VIH
- Agents antirétroviraux
- Inhibiteurs de protéase
- Inhibiteurs du cytochrome P-450 CYP3A
- Inhibiteurs des enzymes du cytochrome P-450
- Inhibiteurs de la protéase du VIH
- Inhibiteurs de la protéase virale
- Ritonavir
- Tipranavir
- Sulfate d'atazanavir
Autres numéros d'identification d'étude
- 1182.61
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur En bonne santé
-
AstraZenecaParexelComplété