Diabetes Mellitus Type 2Phase 1NCT01807377
Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects
A Phase 1 study testing PF-05175157 and Midazolam in people with Diabetes Mellitus Type 2, run by Pfizer at 1 site in United States.
Trial summary
This study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of PF-05175157 administered twice daily for 14 days in healthy overweight and obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- PF-05175157 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Aug 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
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- 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 25 to 35 kg/m2 inclusive; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Evidence or history of any chronic ongoing or current pulmonary disease.
- History of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products. Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Chula Vista, California, 91911
About this study
Official title: A Phase 1 Placebo-Controlled Study To Assess Safety, Tolerability, Pharmacokinetics And Effect On Midazolam Pharmacokinetics Of Multiple Oral Doses Of PF-05175157 Administered In A Tablet Formulation In Otherwise Healthy Overweight And Obese Subjects
This study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of PF-05175157 administered twice daily for 14 days in healthy overweight and obese subjects.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- PF-05175157, Midazolam, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05175157Drug
200 mg tablet administered twice per day for 14 days
MidazolamDrug
2mg administered as single doses on Days 0 and 11
PlaceboOther
Placebo administered twice per day for 14 days
MidazolamDrug
2mg administered as single doses on Days 0 and 11
| Study group | Role | What they receive |
|---|---|---|
| PF-05175157, Midazolam | Experimental | Day 0: Midazolam 2 mg administered alone Days 1-14: 200 mg PF-05175157 administered BID Day 11: Midazolam and PF-05175157 Receives: Drug: PF-05175157; Drug: Midazolam |
| Placebo, Midazolam | Experimental | Day 0: Midazolam 2 mg administered alone Days 1-14: Placebo administered BID Day 11: Midazolam and Placebo Receives: Other: Placebo; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma PF-05175157 Concentration (Cmax)
Single Dose
Measured: 0 - 10 hrs postdose
Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau)
Single Dose
Measured: 0 - 10 hrs postdose
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)
Single Dose
Measured: 0 - 10 hrs postdose
Maximum Observed Plasma PF-05175157 Concentration (Cmax)
Steady State
Measured: 0 - 48 hours postdose
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157
Steady State
Measured: 0 - 48 hours postdose
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)
Steady State
Measured: 0 - 48 hours postdose
Apparent Oral Clearance of PF-05175157 (CL/F)
Measured: 0 - 48 hours postdose
Accumulation Ratio of PF-05175157 (Rac)
Measured: 0 - 10 hours postdose
Plasma Decay Half-Life of PF-05175157 (t1/2)
Measured: 0 - 48 hours postdose
Apparent Volume of Distribution of PF-05175157 (Vz/F)
Measured: 0 - 48 hours postdose
Urinary Recovery for PF-05175157 (AE24)
Amount of PF-05175157 recovered in urine over 24 hours
Measured: 0 - 24 hours postdose
Renal Clearance for PF-05175157 (CLr)
Measured: 0 - 24 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)]
Measured: 0 - 48 hours postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)]
Measured: 0 - 48 hours postdose
Maximum Observed Plasma Concentration for midazolam (Cmax)
Measured: 0 - 48 hours postdose
Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax)
Measured: 0 - 48 hours post dose
Plasma Decay Half-Life of midazolam (t1/2)
Measured: 0 - 48 hours postdose
Fasting triglycerides
Measured: 14 days
Total cholesterol
Measured: 14 days
LDL cholesterol
Measured: 14 days
HDL cholesterol
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- 15 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
- NCT01807377
- Sponsor's protocol ID
- B1731021
- Status last verified
- Sep 2013
- First submitted
- 6 Mar 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Placebo-Controlled Study To Assess Safety, Tolerability, Pharmacokinetics And Effect On Midazolam Pharmacokinetics Of Multiple Oral Doses Of PF-05175157 Administered In A Tablet Formulation In Otherwise Healthy Overweight And Obese Subjects
- ClinicalTrials.gov ID
- NCT01807377
- Acronym / sponsor ID
- B1731021
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 8 Mar 2013 (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 study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of PF-05175157 administered twice daily for 14 days in healthy overweight and obese subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-05175157, Midazolam | Experimental | Drug: PF-05175157, Drug: MidazolamDay 0: Midazolam 2 mg administered alone Days 1-14: 200 mg PF-05175157 administered BID Day 11: Midazolam and PF-05175157 |
| Placebo, Midazolam | Experimental | Other: Placebo, Drug: MidazolamDay 0: Midazolam 2 mg administered alone Days 1-14: Placebo administered BID Day 11: Midazolam and Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- 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 25 to 35 kg/m2 inclusive; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Evidence or history of any chronic ongoing or current pulmonary disease.
- History of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products. Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
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-05175157200 mg tablet administered twice per day for 14 days | Drug | PF-05175157, Midazolam |
| Midazolam2mg administered as single doses on Days 0 and 11 | Drug | PF-05175157, Midazolam |
| PlaceboPlacebo administered twice per day for 14 days | Other | Placebo, Midazolam |
| Midazolam2mg administered as single doses on Days 0 and 11 | Drug | Placebo, Midazolam |
Primary outcome
Maximum Observed Plasma PF-05175157 Concentration (Cmax)
Time frame: 0 - 10 hrs postdose
Single Dose
Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau)
Time frame: 0 - 10 hrs postdose
Single Dose
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)
Time frame: 0 - 10 hrs postdose
Single Dose
Maximum Observed Plasma PF-05175157 Concentration (Cmax)
Time frame: 0 - 48 hours postdose
Steady State
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157
Time frame: 0 - 48 hours postdose
Steady State
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)
Time frame: 0 - 48 hours postdose
Steady State
Apparent Oral Clearance of PF-05175157 (CL/F)
Time frame: 0 - 48 hours postdose
Accumulation Ratio of PF-05175157 (Rac)
Time frame: 0 - 10 hours postdose
Plasma Decay Half-Life of PF-05175157 (t1/2)
Time frame: 0 - 48 hours postdose
Apparent Volume of Distribution of PF-05175157 (Vz/F)
Time frame: 0 - 48 hours postdose
Urinary Recovery for PF-05175157 (AE24)
Time frame: 0 - 24 hours postdose
Amount of PF-05175157 recovered in urine over 24 hours
Renal Clearance for PF-05175157 (CLr)
Time frame: 0 - 24 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)]
Time frame: 0 - 48 hours postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)]
Time frame: 0 - 48 hours postdose
Maximum Observed Plasma Concentration for midazolam (Cmax)
Time frame: 0 - 48 hours postdose
Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax)
Time frame: 0 - 48 hours post dose
Plasma Decay Half-Life of midazolam (t1/2)
Time frame: 0 - 48 hours postdose
Fasting triglycerides
Time frame: 14 days
Total cholesterol
Time frame: 14 days
LDL cholesterol
Time frame: 14 days
HDL cholesterol
Time frame: 14 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 17 Sep 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-05175157 and Midazolam in people with Diabetes Mellitus Type 2, run by Pfizer at 1 site in United States.
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 6 inclusion and 3 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 17 Sep 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 United States. 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 PF-05175157 Concentration (Cmax) (time frame: 0 - 10 hrs postdose). The study lists 21 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 17 Sep 2013.