Phase 1
N=50
Safety and Tolerability of Ascending Intravenous Doses of PF-05231023 In Adult Subjects With Type 2 Diabetes
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01396187 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Jan 2015
Primary outcome: Primary: Number of Participants With Abnormal Physical Examination Findings
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-05231023 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Abnormal Physical Examination Findings |
— | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
5; 6; 3; 8; 10; 0 | — |
| PRIMARY Number of Participants With Abnormal Laboratory Values |
8; 10; 9; 9; 10 | — |
| PRIMARY Number of Participants With Vital Signs Abnormalities |
0; 0; 2; 0; 1; 0 | — |
| PRIMARY Number of Participants With Electrocardiogram (ECG) Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Blood Glucose Abnormalities |
0; 0; 0; 0; 0; 6 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose |
12680; 58780; 229500; 365300; 33240; 186800 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose |
1.02; 1.26; 1.25; 1.50; 1.50; 1.50 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose |
1270; 5991; 23500; 34390; 1182; 7123 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 at Steady State |
14810; 73940; 324300; 453400; 65420; 317800 | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05231023 at Steady State |
11280; 52710; 294100; 456700; 121900; 590400 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 at Steady State |
1.42; 1.48; 1.40; 1.01; 1.48; 1.45 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-05231023 at Steady State |
1239; 5629; 27240; 37160; 1839; 9016 | — |
| SECONDARY Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval of PF-05231023 (Rac) |
1.258; 1.258; 1.413; 1.173; 2.016; 1.702 | — |
| SECONDARY Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF- 05231023 |
0.9992; 0.9392; 1.159; 1.033; 1.626; 1.266 | — |
| SECONDARY Plasma Terminal Half-Life (t1/2) of PF-05231023 at Steady State |
6.484; 7.879; 9.563; 10.25; 83.93; 84.38 | — |
| SECONDARY Apparent Clearance (CL) of PF-05231023 at Steady State |
0.3378; 0.3383; 0.3083; 0.3086; 0.07642; 0.07871 | — |
| SECONDARY Volume of Distribution of PF-05231023 at Steady State (Vss) |
1.467; 1.873; 2.940; 4.110; 7.320; 7.594 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 at Steady State |
0.0003894; 0.1538; 80.51; 218.8; 550.5; 1861 | — |
| SECONDARY Average Plasma Concentration (Cav) of PF-05231023 at Steady State |
205.5; 1027; 4504; 6300; 908.6; 4411 | — |
Summary
This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple ascending doses of PF-05231023.
Eligibility Criteria
Inclusion Criteria
- Male subjects and female subjects of non-childbearing potential between the ages of 30 and 70 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American Diabetes Association guidelines. Subjects who have other conditions but are well controlled by either diet or medications may be included as well (for example, a subject with high cholesterol level on appropriate treatment is eligible).
- Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight >50 kg (110 lbs).
Exclusion Criteria
- 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).
- Diagnosis of Type 1 diabetes mellitus.
- Evidence of diabetic complications with significant end organ damage
Data sourced from ClinicalTrials.gov (NCT01396187). 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.