HealthyPhase 1B521MADNCT01707082
A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults
A Phase 1 study testing PF-06282999 and midazolam in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
Part A of the study will test the safety, the amount of drug in the body, and effects of the drug in the body after multiple doses. This will be conducted in healthy overweight adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06282999 and midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2012to May 2013
- 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 (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Women must be of non childbearing potential.
- Body Mass Index (BMI) of 27.0 to 35.0 kg/m2 (Part A) or 17.5 to 30.5 kg/m2 (Part B); and a total body weight >50 kg (110 lbs).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Subject with any contraindication to midazolam according to the country specific labeling or subject with previous intolerance or allergy to benzodiazepines (applicable to Part B of study only).
- Subjects who were enrolled in Part A are excluded from participation in Part B of this study.
- Subjects who have previously participated in a study with PF-06282999.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Multiple Dose Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of PF-06282999 In Healthy Overweight Subjects And A Fixed-Sequence Study To Assess The Effect Of PF-06282999 On The Pharmacokinetics Of Midazolam In Healthy Subjects
Part A of the study will test the safety, the amount of drug in the body, and effects of the drug in the body after multiple doses. This will be conducted in healthy overweight adults. Part B of the study will test the effects of multiple doses of the investigational drug on the amount of midazolam, an approved drug, in healthy adults.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06282999Drug
Tablet, 10 mg, every 8 hours, 14 days
PlaceboDrug
Tablet, 0 mg, every 8 hours, 14 days
PF-06282999Drug
Tablet, 30 mg, every 8 hours, 14 days
PlaceboDrug
Tablet, 0 mg, every 8 hours, 14 days
PF-06282999Drug
Tablet, 100 mg, every 8 hours, 14 days
PlaceboDrug
Tablet, 0 mg, every 8 hours, 14 days
PF-06282999Drug
Tablet, 250 mg, every 8 hours, 14 days
PlaceboDrug
Tablet, 0 mg, every 8 hours, 14 days
PF-06282999Drug
Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days
PlaceboDrug
Tablet, 0 mg, every 8 or 12 hours, 14 days
midazolamDrug
Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
PF-06282999Drug
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
midazolamDrug
Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
PF-06282999Drug
Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
| Study group | Role | What they receive |
|---|---|---|
| Part A Cohort 1 | Experimental | Not described Receives: Drug: PF-06282999; Drug: Placebo |
| Part A Cohort 2 | Experimental | Not described Receives: Drug: PF-06282999; Drug: Placebo |
| Part A Cohort 3 | Experimental | Not described Receives: Drug: PF-06282999; Drug: Placebo |
| Part A Cohort 4 | Experimental | Not described Receives: Drug: PF-06282999; Drug: Placebo |
| Part A Cohort 5 | Experimental | Not described Receives: Drug: PF-06282999; Drug: Placebo |
| Part B Cohort 1 | Experimental | Not described Receives: Drug: midazolam; Drug: PF-06282999 |
| Part B Cohort 2 | Experimental | Not described Receives: Drug: midazolam; Drug: PF-06282999 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Measured: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Apparent Oral Clearance (CL/F)
Measured: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Maximum Observed Plasma Concentration (Cmax)
Measured: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Measured: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Minimum Observed Plasma Trough Concentration (Cmin)
Measured: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Apparent Oral Clearance (CL/F)
Measured: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Plasma Decay Half-Life (t1/2)
Measured: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam
Measured: Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam
Measured: -2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). Midazolam
Measured: Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). Midazolam
Measured: -2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
Maximum Observed Plasma Concentration (Cmax)
Measured: Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
Maximum Observed Plasma Concentration (Cmax)
Measured: -2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
Average Concentration (Cav)
Measured: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Accumulation Ratio
Measured: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Secondary outcomes (12)
Diastolic Blood Pressure
Mean 24-hour average diastolic blood pressure
Measured: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Diastolic Blood Pressure
Mean 24-hour average diastolic blood pressure
Measured: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Systolic Blood Pressure
Mean 24-hour average systolic blood pressure
Measured: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Systolic Blood Pressure
Mean 24-hour average systolic blood pressure
Measured: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
interleukin-6
Measured: Days 1 and 14 pre-dose Part A
high-sensitivity C-reactive protein
Measured: Days 1 and 14 pre-dose Part A
total cholesterol, HDL-C, triglycerides and calculated LDL-C
Measured: Days 1 and 14 pre-dose Part A
ApoBTotal,ApoB48, ApoB100, ApoA-1
Measured: Days 1 and 14 pre-dose Part A
Diastolic Blood Pressure
Mean 24-hour average diastolic blood pressure
Measured: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Diastolic Blood Pressure
Mean 24-hour average diastolic blood pressure
Measured: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Systolic Blood Pressure
Mean 24-hour average systolic blood pressure
Measured: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Systolic Blood Pressure
Mean 24-hour average systolic blood pressure
Measured: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionMay 2013
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707082
- Sponsor's protocol ID
- B5211002
- Acronym
- B521MAD
- Status last verified
- Jul 2013
- First submitted
- 3 Oct 2012
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Multiple Dose Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of PF-06282999 In Healthy Overweight Subjects And A Fixed-Sequence Study To Assess The Effect Of PF-06282999 On The Pharmacokinetics Of Midazolam In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01707082
- Acronym / sponsor ID
- B521MAD / B5211002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Oct 2012 (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.
Part A of the study will test the safety, the amount of drug in the body, and effects of the drug in the body after multiple doses. This will be conducted in healthy overweight adults. Part B of the study will test the effects of multiple doses of the investigational drug on the amount of midazolam, an approved drug, in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A Cohort 1 | Experimental | Drug: PF-06282999, Drug: Placebo |
| Part A Cohort 2 | Experimental | Drug: PF-06282999, Drug: Placebo |
| Part A Cohort 3 | Experimental | Drug: PF-06282999, Drug: Placebo |
| Part A Cohort 4 | Experimental | Drug: PF-06282999, Drug: Placebo |
| Part A Cohort 5 | Experimental | Drug: PF-06282999, Drug: Placebo |
| Part B Cohort 1 | Experimental | Drug: midazolam, Drug: PF-06282999 |
| Part B Cohort 2 | Experimental | Drug: midazolam, Drug: PF-06282999 |
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 (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Women must be of non childbearing potential.
- Body Mass Index (BMI) of 27.0 to 35.0 kg/m2 (Part A) or 17.5 to 30.5 kg/m2 (Part B); and a total body weight >50 kg (110 lbs).
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Subject with any contraindication to midazolam according to the country specific labeling or subject with previous intolerance or allergy to benzodiazepines (applicable to Part B of study only).
- Subjects who were enrolled in Part A are excluded from participation in Part B of this study.
- Subjects who have previously participated in a study with PF-06282999.
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-06282999Tablet, 10 mg, every 8 hours, 14 days | Drug | Part A Cohort 1 |
| PlaceboTablet, 0 mg, every 8 hours, 14 days | Drug | Part A Cohort 1 |
| PF-06282999Tablet, 30 mg, every 8 hours, 14 days | Drug | Part A Cohort 2 |
| PlaceboTablet, 0 mg, every 8 hours, 14 days | Drug | Part A Cohort 2 |
| PF-06282999Tablet, 100 mg, every 8 hours, 14 days | Drug | Part A Cohort 3 |
| PlaceboTablet, 0 mg, every 8 hours, 14 days | Drug | Part A Cohort 3 |
| PF-06282999Tablet, 250 mg, every 8 hours, 14 days | Drug | Part A Cohort 4 |
| PlaceboTablet, 0 mg, every 8 hours, 14 days | Drug | Part A Cohort 4 |
| PF-06282999Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days | Drug | Part A Cohort 5 |
| PlaceboTablet, 0 mg, every 8 or 12 hours, 14 days | Drug | Part A Cohort 5 |
| midazolamTablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14 | Drug | Part B Cohort 1 |
| PF-06282999Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days | Drug | Part B Cohort 1 |
| midazolamTablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14 | Drug | Part B Cohort 2 |
| PF-06282999Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days | Drug | Part B Cohort 2 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Apparent Oral Clearance (CL/F)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Minimum Observed Plasma Trough Concentration (Cmin)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Apparent Oral Clearance (CL/F)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Plasma Decay Half-Life (t1/2)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: -2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) Midazolam
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). Midazolam
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: -2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). Midazolam
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,8,10,12 and 16 hrs post dose Day 1 Period 1 Part B
Maximum Observed Plasma Concentration (Cmax)
Time frame: -2,-1.5,-1,Pre-dose,1,2,4,6,8,10,14 Day 14 Period 2 Part B
Average Concentration (Cav)
Time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
Accumulation Ratio
Time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8,10,12,16,24,36, and 48 hrs post morning dose Day 14 Part A
12 secondary outcomes
Diastolic Blood Pressure
Time frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Diastolic Blood Pressure
Time frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Systolic Blood Pressure
Time frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
Systolic Blood Pressure
Time frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part A
interleukin-6
Time frame: Days 1 and 14 pre-dose Part A
high-sensitivity C-reactive protein
Time frame: Days 1 and 14 pre-dose Part A
total cholesterol, HDL-C, triglycerides and calculated LDL-C
Time frame: Days 1 and 14 pre-dose Part A
ApoBTotal,ApoB48, ApoB100, ApoA-1
Time frame: Days 1 and 14 pre-dose Part A
Diastolic Blood Pressure
Time frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Diastolic Blood Pressure
Time frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Systolic Blood Pressure
Time frame: Day 1 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
Systolic Blood Pressure
Time frame: Day 13 Pre-dose,1,2,4,8,12 and 16 hrs post dose Part B
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 31 Jul 2013.
- 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-06282999 and midazolam in people with Healthy, 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 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: finished, as of the sponsor's last update on 31 Jul 2013. 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?
Maximum Observed Plasma Concentration (Cmax) (time frame: Pre-dose,0.5,1,2,3,4,5,6,7,8 and 16 hrs post morning dose Day 1 Part A). The study lists 18 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 31 Jul 2013.