Phase 1
N=64
A Study of PF-05175157 in Healthy Volunteers and Type 2 Diabetic Patients
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01396161 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 2; 2; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-05175157 or Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
2; 2; 1; 1; 2; 5 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
3.07; 7.52; 21.75; 15.18; 23.26 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
4.00; 1.00; 4.00; 3.00; 4.00 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) |
32.86; 90.50; 255.9; 125.6; 282.6 | — |
| SECONDARY Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC) |
1.39; 1.01; 1.47; 2.53; 1.54 | — |
| SECONDARY Renal Clearance (CLr) |
5.48; 5.30; 4.57; 5.93; 5.42 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) |
— | — |
| SECONDARY Urinary Recovery |
35.59; 27.30; 33.75; 43.60; 44.31 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01396161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.