- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
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: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maximum plasma concentration
Tidsramme: up to day 33
|
up to day 33
|
Drug concentration in plasma at 12 hr after administration for Tipranavir (TPV) and Ritonavir (RTV)
Tidsramme: 12 hours after drug administration
|
12 hours after drug administration
|
Drug concentration in plasma at 24 hr after administration for Atazanavir (TAZ)
Tidsramme: 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
Tidsramme: up to 12 hours after drug administration
|
up to 12 hours after drug administration
|
AUC0-24h for TAZ
Tidsramme: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Time from dosing to the maximum concentration
Tidsramme: up to day 33
|
up to day 33
|
Elimination half-life
Tidsramme: up to day 33
|
up to day 33
|
Oral clearance
Tidsramme: up to day 33
|
up to day 33
|
Volume of distribution
Tidsramme: up to day 33
|
up to day 33
|
Number of patients with adverse events
Tidsramme: up to day 33
|
up to day 33
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1182.61
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