Healthy VolunteersPhase 1NCT00783484
A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects
A Phase 1 study testing PF-03716539, Midazolam and Midazolam + PF-03716539 (100 mg) in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.
Trial summary
First in human study to evaluate the safety, tolerability, and pharmacokinetics of PF-03716539. The potential of PF-03716539 to increase the concentrations of midazolam, darunavir and maraviroc will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PF-03716539, Midazolam and Midazolam + PF-03716539 (100 mg)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2008to May 2009
- 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 18 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 18 and 55 years, inclusive.
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2. Total body weight >50 kg (110 lbs).
Who cannot join
- Pregnant or nursing females. females of childbearing potential. Evidence or history of clinically significant hematological, renal (including kidney stones), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at screening.
- Treatment with an investigational drug within 30 days (or determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind (3rd Party Open), Placebo-Controlled, Crossover, Dose Escalating Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539, To Assess The Potential Of PF-03716539 To Inhibit CYP3A4 (In Vivo) And To Evaluate The Drug Interaction Potential Between PF-03716539 And Darunavir Or Maraviroc In Healthy Adult Subjects
First in human study to evaluate the safety, tolerability, and pharmacokinetics of PF-03716539. The potential of PF-03716539 to increase the concentrations of midazolam, darunavir and maraviroc will also be evaluated.
- Conditions
- Healthy Volunteers
- Being tested
- PF-03716539, Placebo, Midazolam, Midazolam + PF-03716539 (100 mg), Midazolam + PF-03716539 (50 mg)
- Keywords
- First in Human (FIH), PF-03716539, PK enhancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-03716539Drug
PF-03716539 10 mg oral solution, single dose
PF-03716539Drug
PF-03716539 25 mg oral solution, single dose
PF-03716539Drug
PF-03716539 3 mg oral solution, single dose
PlaceboOther
Placebo for 3 mg, 10 mg and 25 mg of PF-03716539 (single dose)
PF-03716539Drug
PF-03716539 100 mg oral solution, single dose
PF-03716539Drug
PF-03716539 200 mg oral solution, single dose
PF-03716539Drug
PF-03716539 50 mg oral solution, single dose
PlaceboOther
Placebo for 50 mg, 100 mg and 200 mg of PF-03716539 (single dose)
MidazolamDrug
Midazolam 1 mg IV, single dose
Midazolam + PF-03716539 (100 mg)Drug
Midazolam 1 mg IV, single dose plus PF-03716539 100 mg oral solution, single dose
Midazolam + PF-03716539 (50 mg)Drug
Midazolam 1 mg IV, single dose plus PF-03716539 50 mg oral solution, single dose
DarunavirDrug
Darunavir 600 mg tablet twice daily for 9 days (Days 1-9)
Darunavir + PF-03716539Drug
Darunavir 600 mg tablet, single dose plus PF-03716539 50 mg oral solution, single dose (Day 10)
MaravirocDrug
Also called Selzentry
Maraviroc 150 mg tablet once daily for 6 days (Days 1-6)
Maraviroc +PF-03716539Drug
Also called Selzentry
Maraviroc 150 mg tablet, single dose plus PF-03716539 100 mg oral solution, single dose (Day 7)
MaravirocDrug
Also called Selzentry
Maraviroc 225 mg tablet once daily for 6 days (Days 1-6)
Maraviroc +PF-03716539Drug
Also called Selzentry
Maraviroc 225 mg tablet, single dose plus PF-03716539 200 mg oral solution, single dose (Day 7)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | PF-03716539 crossover, single dose escalation (doses subject to change). Receives: Drug: PF-03716539; Other: Placebo |
| Cohort 2 | Experimental | PF-03716539 crossover, single dose escalation (doses subject to change). Receives: Drug: PF-03716539; Other: Placebo |
| Cohort 3 | Experimental | Midazolam-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change). Receives: Drug: Midazolam; Drug: Midazolam + PF-03716539 (100 mg); Drug: Midazolam + PF-03716539 (50 mg) |
| Cohort 4 | Experimental | Darunavir-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change). Receives: Drug: Darunavir; Drug: Darunavir + PF-03716539 |
| Cohort 5 | Experimental | Maraviroc-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change). Receives: Drug: Maraviroc; Drug: Maraviroc +PF-03716539 |
| Cohort 6 | Experimental | Maraviroc-PF-03716539 drug-drug interaction (PF-03716539 200 mg). Receives: Drug: Maraviroc; Drug: Maraviroc +PF-03716539 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of escalating single oral doses of PF 03716539 administered as Extemporaneous Powder for Solution (EPS) in healthy adult subjects.
Measured: 27 days
To explore the pharmacokinetics of escalating single oral doses of PF 03716539 in healthy adult subjects.
Measured: 6 days
Secondary outcomes (2)
To assess the potency of PF 03716539 for CYP3A4 inhibition utilizing single dose IV midazolam as a probe substrate for CYP3A4/5.
Measured: 6 days
To evaluate the potential of PF 03716539 to enhance or "boost" the pharmacokinetics of both darunavir and maraviroc.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783484
- Sponsor's protocol ID
- B0831001
- Status last verified
- May 2009
- First submitted
- 30 Oct 2008
- Last updated
- 2 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind (3rd Party Open), Placebo-Controlled, Crossover, Dose Escalating Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539, To Assess The Potential Of PF-03716539 To Inhibit CYP3A4 (In Vivo) And To Evaluate The Drug Interaction Potential Between PF-03716539 And Darunavir Or Maraviroc In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00783484
- Acronym / sponsor ID
- B0831001
- Conditions
- Healthy Volunteers
- Keywords
- First in Human (FIH), PF-03716539, PK enhancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 31 Oct 2008 (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.
First in human study to evaluate the safety, tolerability, and pharmacokinetics of PF-03716539. The potential of PF-03716539 to increase the concentrations of midazolam, darunavir and maraviroc will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PF-03716539, Other: PlaceboPF-03716539 crossover, single dose escalation (doses subject to change). |
| Cohort 2 | Experimental | Drug: PF-03716539, Other: PlaceboPF-03716539 crossover, single dose escalation (doses subject to change). |
| Cohort 3 | Experimental | Drug: Midazolam, Drug: Midazolam + PF-03716539 (100 mg), Drug: Midazolam + PF-03716539 (50 mg)Midazolam-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change). |
| Cohort 4 | Experimental | Drug: Darunavir, Drug: Darunavir + PF-03716539Darunavir-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change). |
| Cohort 5 | Experimental | Drug: Maraviroc, Drug: Maraviroc +PF-03716539Maraviroc-PF-03716539 drug-drug interaction (PF-03716539 doses subject to change). |
| Cohort 6 | Experimental | Drug: Maraviroc, Drug: Maraviroc +PF-03716539Maraviroc-PF-03716539 drug-drug interaction (PF-03716539 200 mg). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2. Total body weight >50 kg (110 lbs).
Key exclusion criteria (2 listed)
- Pregnant or nursing females. females of childbearing potential. Evidence or history of clinically significant hematological, renal (including kidney stones), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at screening.
- Treatment with an investigational drug within 30 days (or determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
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 |
|---|---|---|
| PF-03716539PF-03716539 10 mg oral solution, single dose | Drug | Cohort 1 |
| PF-03716539PF-03716539 25 mg oral solution, single dose | Drug | Cohort 1 |
| PF-03716539PF-03716539 3 mg oral solution, single dose | Drug | Cohort 1 |
| PlaceboPlacebo for 3 mg, 10 mg and 25 mg of PF-03716539 (single dose) | Other | Cohort 1 |
| PF-03716539PF-03716539 100 mg oral solution, single dose | Drug | Cohort 2 |
| PF-03716539PF-03716539 200 mg oral solution, single dose | Drug | Cohort 2 |
| PF-03716539PF-03716539 50 mg oral solution, single dose | Drug | Cohort 2 |
| PlaceboPlacebo for 50 mg, 100 mg and 200 mg of PF-03716539 (single dose) | Other | Cohort 2 |
| MidazolamMidazolam 1 mg IV, single dose | Drug | Cohort 3 |
| Midazolam + PF-03716539 (100 mg)Midazolam 1 mg IV, single dose plus PF-03716539 100 mg oral solution, single dose | Drug | Cohort 3 |
| Midazolam + PF-03716539 (50 mg)Midazolam 1 mg IV, single dose plus PF-03716539 50 mg oral solution, single dose | Drug | Cohort 3 |
| DarunavirDarunavir 600 mg tablet twice daily for 9 days (Days 1-9) | Drug | Cohort 4 |
| Darunavir + PF-03716539Darunavir 600 mg tablet, single dose plus PF-03716539 50 mg oral solution, single dose (Day 10) | Drug | Cohort 4 |
| MaravirocAlso: SelzentryMaraviroc 150 mg tablet once daily for 6 days (Days 1-6) | Drug | Cohort 5 |
| Maraviroc +PF-03716539Also: SelzentryMaraviroc 150 mg tablet, single dose plus PF-03716539 100 mg oral solution, single dose (Day 7) | Drug | Cohort 5 |
| MaravirocAlso: SelzentryMaraviroc 225 mg tablet once daily for 6 days (Days 1-6) | Drug | Cohort 6 |
| Maraviroc +PF-03716539Also: SelzentryMaraviroc 225 mg tablet, single dose plus PF-03716539 200 mg oral solution, single dose (Day 7) | Drug | Cohort 6 |
Primary outcome
To evaluate the safety and tolerability of escalating single oral doses of PF 03716539 administered as Extemporaneous Powder for Solution (EPS) in healthy adult subjects.
Time frame: 27 days
To explore the pharmacokinetics of escalating single oral doses of PF 03716539 in healthy adult subjects.
Time frame: 6 days
2 secondary outcomes
To assess the potency of PF 03716539 for CYP3A4 inhibition utilizing single dose IV midazolam as a probe substrate for CYP3A4/5.
Time frame: 6 days
To evaluate the potential of PF 03716539 to enhance or "boost" the pharmacokinetics of both darunavir and maraviroc.
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2009.
- 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 PF-03716539, Midazolam and Midazolam + PF-03716539 (100 mg) in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 2 Jun 2009. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the safety and tolerability of escalating single oral doses of PF 03716539 administered as Extemporaneous Powder for Solution (EPS) in healthy adult subjects. (time frame: 27 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 2 Jun 2009.