Clinical trial NCT01396187: Safety and Tolerability of Ascending Intravenous Doses of PF-05231023 In Adult Subjects With Type 2 Diabetes
Official title: A Phase 1, Placebo-Controlled Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Ascending Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
safety
multiple dose
intravenous
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Participants With Abnormal Physical Examination Findings
timeFrame: Baseline up to Day 42
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 77
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: Baseline up to Day 42
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: Baseline up to Day 77
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Day 77
measure: Number of Participants With Blood Glucose Abnormalities
timeFrame: Baseline up to Day 32
Secondary outcomes:
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose
timeFrame: 0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose
timeFrame: 0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3
measure: Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose
timeFrame: 0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 at Steady State
timeFrame: 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05231023 at Steady State
timeFrame: 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 at Steady State
timeFrame: 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29
measure: Maximum Observed Plasma Concentration (Cmax) of PF-05231023 at Steady State
timeFrame: 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29
measure: Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval of PF-05231023 (Rac)
timeFrame: 0 hour (pre-dose) on Day 1, 4, 25; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1, 25; Day 2, 3, 26, 29
measure: Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF- 05231023
timeFrame: 0 hour (pre-dose) on Day 1, 4, 25; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1, 25; Day 2, 3, 26, 29
measure: Plasma Terminal Half-Life (t1/2) of PF-05231023 at Steady State
timeFrame: 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29
measure: Apparent Clearance (CL) of PF-05231023 at Steady State
timeFrame: 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29
measure: Volume of Distribution of PF-05231023 at Steady State (Vss)
timeFrame: 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29
measure: Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 at Steady State
timeFrame: 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29
measure: Average Plasma Concentration (Cav) of PF-05231023 at Steady State
timeFrame: 0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: