HealthyPhase 1NCT01140412
Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
A Phase 1 study testing Maraviroc, Fosamprenavir/ritonavir and Maraviroc + Fosamprenavir/ritonavir in people with Healthy, run by ViiV Healthcare at 1 site in Singapore.
Trial summary
This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Maraviroc, Fosamprenavir/ritonavir and Maraviroc + Fosamprenavir/ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2010to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
- Total body weight >45 kg (99 lbs).
Who cannot join
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- Known hypersensitivity or history of allergy to sulfonamides.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Fixed-Sequence, Crossover Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.
- Conditions
- Healthy
- Being tested
- Maraviroc, Fosamprenavir/ritonavir, Maraviroc + Fosamprenavir/ritonavir
- Keywords
- maraviroc, fosamprenavir, drug interaction, pharmacokinetics, HIV, AIDS, CCR5, protease inhibitor
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaravirocDrug
Also called Selzentry, Celsentri
maraviroc 300 mg BID x 5 days
Fosamprenavir/ritonavirDrug
fosamprenavir/ritonavir 700/100 mg BID x 10 days
Maraviroc + Fosamprenavir/ritonavirDrug
maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days
MaravirocDrug
Also called Selzentry, Celsentri
maraviroc 300 mg QD x 5 days
Fosamprenavir/ritonavirDrug
fosamprenavir/ritonavir 1400/100 mg QD x 10 days
Maraviroc + Fosamprenavir/ritonavirDrug
maraviroc 300 mg QD + fosamprenavir/ritonavir 1400/100 mg QD x 10 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Twice daily regimen Receives: Drug: Maraviroc; Drug: Fosamprenavir/ritonavir; Drug: Maraviroc + Fosamprenavir/ritonavir |
| Cohort 2 | Experimental | Once daily regimen Receives: Drug: Maraviroc; Drug: Fosamprenavir/ritonavir; Drug: Maraviroc + Fosamprenavir/ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 1, Day 5 and Period 2, Day 20
Measured: 25 days
Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 2, Day 10 and Period 2, Day 20
Measured: 25 days
Secondary outcomes (3)
Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.
Measured: 25 days
Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.
Measured: 25 days
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments.
Measured: 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: The trial prematurely terminated on November 1, 2010, due to healthy volunteer participants experiencing non-serious fosamprenavir-related skin rash.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140412
- Sponsor's protocol ID
- A4001099
- Status last verified
- Feb 2011
- First submitted
- 7 Jun 2010
- Last updated
- 4 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Fixed-Sequence, Crossover Study To Estimate The Pharmacokinetic Interaction Between Multiple Dose Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01140412
- Acronym / sponsor ID
- A4001099
- Conditions
- Healthy
- Keywords
- maraviroc, fosamprenavir, drug interaction, pharmacokinetics, HIV, AIDS, CCR5, protease inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial prematurely terminated on November 1, 2010, due to healthy volunteer participants experiencing non-serious fosamprenavir-related skin rash.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jul 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Maraviroc, Drug: Fosamprenavir/ritonavir, Drug: Maraviroc + Fosamprenavir/ritonavirTwice daily regimen |
| Cohort 2 | Experimental | Drug: Maraviroc, Drug: Fosamprenavir/ritonavir, Drug: Maraviroc + Fosamprenavir/ritonavirOnce daily regimen |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
- Total body weight >45 kg (99 lbs).
Key exclusion criteria (4 listed)
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
- Known hypersensitivity or history of allergy to sulfonamides.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaravirocAlso: Selzentry, Celsentrimaraviroc 300 mg BID x 5 days | Drug | Cohort 1 |
| Fosamprenavir/ritonavirfosamprenavir/ritonavir 700/100 mg BID x 10 days | Drug | Cohort 1 |
| Maraviroc + Fosamprenavir/ritonavirmaraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days | Drug | Cohort 1 |
| MaravirocAlso: Selzentry, Celsentrimaraviroc 300 mg QD x 5 days | Drug | Cohort 2 |
| Fosamprenavir/ritonavirfosamprenavir/ritonavir 1400/100 mg QD x 10 days | Drug | Cohort 2 |
| Maraviroc + Fosamprenavir/ritonavirmaraviroc 300 mg QD + fosamprenavir/ritonavir 1400/100 mg QD x 10 days | Drug | Cohort 2 |
Primary outcome
Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 1, Day 5 and Period 2, Day 20
Time frame: 25 days
Amprenavir and ritonavir plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 2, Day 10 and Period 2, Day 20
Time frame: 25 days
3 secondary outcomes
Maraviroc plasma pharmacokinetic parameter: Tmax on Period 1, Day 5 and Period 2, Day 20.
Time frame: 25 days
Amprenavir and ritonavir plasma pharmacokinetic parameter: Tmax, on Period 2, Day 10 and Period 2, Day 20.
Time frame: 25 days
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments.
Time frame: 25 days
Results and safety
The study was stopped early (reason given: The trial prematurely terminated on November 1, 2010, due to healthy volunteer participants experiencing non-serious fosamprenavir-related skin rash.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Maraviroc, Fosamprenavir/ritonavir and Maraviroc + Fosamprenavir/ritonavir in people with Healthy, run by ViiV Healthcare at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial prematurely terminated on November 1, 2010, due to healthy volunteer participants experiencing non-serious fosamprenavir-related skin rash.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maraviroc plasma pharmacokinetic parameters: AUCτ, Cmax, and Cτ on Period 1, Day 5 and Period 2, Day 20 (time frame: 25 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2011.