Diabetes Mellitus, Type 2Phase 1NCT01396161

A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients

A Phase 1 study of Diabetes Mellitus, Type 2, run by Pfizer at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of PF-05175157 in healthy volunteers and patients with type 2 diabetes mellitus. 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 3 sitesUnited States
Study dates: Jul 2011to Feb 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.
In addition, subjects must have normal pulmonary function tests and normal ocular examination.
Body Mass Index (BMI) of 25.5 - 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
Women must be of non-childbearing potential.
Subjects with type 2 diabetes: HbA1c ≥7.0% and ≤10.0% if on metformin only, and ≥6.5% and ≤9.0% if patient requires to be washed-off an SU or DPP-4i.
For subjects with type 2 diabetes, due to possible effects on disposition, CYP P450 3A4/5 and 2D6 substrates should not be co-administered with study medications.

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, 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 within 3 months of Screening, or positive cotinine test at Screening or Day -3.
Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Miami Research Associates
South Miami, Florida, 33143
MRA Clinical Research
South Miami, Florida, 33143
Pulmonary Physicians of South Florida
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Phase 1 Placebo-controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Oral Doses Of Pf-05175157 In Healthy Volunteers And In Patients With Type 2 Diabetes Mellitus (t2dm)

Conditions: Diabetes Mellitus, Type 2
Being tested: PF-05175157 or Placebo
Keywords: Phase 1, Multiple Doses, Safety, Pharmacokinetics, Pharmacodynamics, Healthy Volunteers, Type 2 Diabetic Patients
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-05175157 or PlaceboDrug
One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.
PF-05175157 or PlaceboDrug
One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.
PF-05175157 or PlaceboDrug
One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.
PF-05175157 or PlaceboDrug
One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule twice daily for 14 days, immediately before breakfast and dinner, in healthy volunteers.
PF-05175157 or PlaceboDrug
One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once (or twice) daily for 14 days, immediately before breakfast (and dinner), in patients with type 2 diabetes.

Study groups in NCT01396161
Study group	Role	What they receive
30 mg PF-05175157 or Placebo QD	Experimental	Not described Receives: Drug: PF-05175157 or Placebo
100 mg PF-05175157 or Placebo QD	Experimental	Planned dose might be modified based on emerging safety and PK data. Receives: Drug: PF-05175157 or Placebo
200 mg PF-05175157 or Placebo QD	Experimental	Planned dose might be modified based on emerging safety and PK data. Receives: Drug: PF-05175157 or Placebo
100 mg PF-05175157 or Placebo BID	Experimental	Planned dose might be modified based on emerging safety and PK data. Receives: Drug: PF-05175157 or Placebo
xxx mg PF-05175157	Experimental	Dose will be determined based on results obtained from Arms 1 to 4. Receives: Drug: PF-05175157 or Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: 2 weeks

Secondary outcomes (7)

Maximum Observed Plasma Concentration (Cmax)
Measured: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Measured: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC)
Rˇac for the AUC is defined as AUC (τ, single dose [ss]) / AUC (τ, multiple dose [sd]).
Measured: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Renal Clearance (CLr)
CLr is the amount of unchanged drug excreted in the participants urine from time zero to end of dosing interval.
Measured: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Urinary Recovery
Percentage of PF-05175157 excreted unchanged in urine over the dosing interval.
Measured: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Feb 2012

First posted18 Jul 2011 (estimated)
Study startJul 2011
Primary completionFeb 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01396161
Sponsor's protocol ID: B1731007
Status last verified: Sep 2016
First submitted: 20 Jun 2011
Last updated: 7 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Placebo-controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Oral Doses Of Pf-05175157 In Healthy Volunteers And In Patients With Type 2 Diabetes Mellitus (t2dm)
ClinicalTrials.gov ID: NCT01396161
Acronym / sponsor ID: B1731007
Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 1, Multiple Doses, Safety, Pharmacokinetics, Pharmacodynamics, Healthy Volunteers, Type 2 Diabetic Patients
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 18 Jul 2011 (estimated)
Results: Posted 7 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
30 mg PF-05175157 or Placebo QD	Experimental	Drug: PF-05175157 or Placebo
100 mg PF-05175157 or Placebo QD	Experimental	Drug: PF-05175157 or PlaceboPlanned dose might be modified based on emerging safety and PK data.
200 mg PF-05175157 or Placebo QD	Experimental	Drug: PF-05175157 or PlaceboPlanned dose might be modified based on emerging safety and PK data.
100 mg PF-05175157 or Placebo BID	Experimental	Drug: PF-05175157 or PlaceboPlanned dose might be modified based on emerging safety and PK data.
xxx mg PF-05175157	Experimental	Drug: PF-05175157 or PlaceboDose will be determined based on results obtained from Arms 1 to 4.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 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.
In addition, subjects must have normal pulmonary function tests and normal ocular examination.
Body Mass Index (BMI) of 25.5 - 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
Women must be of non-childbearing potential.
Subjects with type 2 diabetes: HbA1c ≥7.0% and ≤10.0% if on metformin only, and ≥6.5% and ≤9.0% if patient requires to be washed-off an SU or DPP-4i.

Key exclusion criteria (4 listed)

Evidence or history of clinically significant hematological, renal, endocrine, 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 within 3 months of Screening, or positive cotinine test at Screening or Day -3.
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-05175157 or PlaceboOne oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.	Drug	30 mg PF-05175157 or Placebo QD
PF-05175157 or PlaceboOne oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.	Drug	100 mg PF-05175157 or Placebo QD
PF-05175157 or PlaceboOne oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.	Drug	200 mg PF-05175157 or Placebo QD
PF-05175157 or PlaceboOne oral dose of PF-05175157 or placebo is administered as a powder-in-capsule twice daily for 14 days, immediately before breakfast and dinner, in healthy volunteers.	Drug	100 mg PF-05175157 or Placebo BID
PF-05175157 or PlaceboOne oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once (or twice) daily for 14 days, immediately before breakfast (and dinner), in patients with type 2 diabetes.	Drug	xxx mg PF-05175157

Primary outcome

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 2 weeks
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

7 secondary outcomes

Maximum Observed Plasma Concentration (Cmax)
Time frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
Time frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC)
Time frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Renal Clearance (CLr)
Time frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Plasma Decay Half-Life (t1/2)
Time frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11
Urinary Recovery
Time frame: Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11

Results and safety

Results posted to the registry on 7 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo - Healthy and Overweight Participants (HOV)	12	12
Placebo - Type 2 Diabetes Mellitus Participants (T2DM)	5	5
PF-05175157 30 mg QD - HOV	9	9
PF-05175157 100 mg QD - HOV	9	9
PF-05175157 200 mg QD - HOV	9	8
PF-05175157 100 mg BID - HOV	9	9
PF-05175157 200 mg QD - T2DM	11	10

Primary outcome: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: 2 weeks. Number. Unit: participants

Measure	Placebo - HOV n = 12	Placebo - T2DM n = 5	PF-05175157 30 mg QD - HOV n = 9	PF-05175157 100 mg QD - HOV n = 9	PF-05175157 200 mg QD - HOV n = 9	PF-05175157 100 mg BID - HOV n = 9	PF-05175157 200 mg QD - T2DM n = 11
AEs	2	2	1	1	2	5	3
SAEs	0	0	0	0	0	0	0

Population analysed: Safety Analysis Set: all participants who received at least 1 dose of study medication (PF-05175157 or placebo).

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - HOV	0 of 12 (0%)	2 of 12 (16.7%)	Not reported
Placebo - T2DM	0 of 5 (0%)	2 of 5 (40%)	Not reported
PF-05175157 30 mg QD - HOV	0 of 9 (0%)	1 of 9 (11.1%)	Not reported
PF-05175157 100 mg QD - HOV	0 of 9 (0%)	1 of 9 (11.1%)	Not reported
PF-05175157 200 mg QD - HOV	0 of 9 (0%)	2 of 9 (22.2%)	Not reported
PF-05175157 100 mg BID - HOV	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
PF-05175157 200 mg QD - T2DM	0 of 11 (0%)	3 of 11 (27.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Diabetes Mellitus, Type 2, run by Pfizer at 3 sites 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 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 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 7 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01396161.

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 7 Nov 2016.