A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Biological: CVX-096

• Registration Number: NCT00886821
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2017-03
• Results First Submitted: 2017-03-02
• Results First Submitted QC: 2017-03-06
• Last Update Submitted: 2017-03-06
• Results First Posted: 2017-04-18
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum.
• Hb A1c between 7-10%.
• Fasting C-peptide >0.4 nmol/L.

Exclusion Criteria

• History of clinically significant chronic conditions other than T2DM not well controlled by either diet or medications.
• Patients with pancreatitis or considered a high risk for pancreatitis.
• History of contraindications to metformin therapy.
• Previous treatment with an approved or investigational GLP 1 mimetic.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CVX-096	-

Primary Outcome Measures

Name	Time	Method
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1	Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1
Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8	pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1	pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1	AUClast was defined as area under the concentration-time curve from time zero to the time of last measured concentration and calculated by using linear up/log down trapezoidal method.
Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22	pre-dose, 1 and 6 hours post-dose on Day 22
Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1	Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1
Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8	pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8
Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22	pre-dose, 1 and 6 hours post-dose on Day 22

Secondary Outcome Measures

Name	Time	Method
Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22	pre-dose, 1 and 6 hours post-dose on Day 22	Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1	pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1	MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method and AUC(0 - inf) is the area under the concentration-time curve extrapolated to infinity.
Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1	pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1	Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug apparent oral clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1	pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1	Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8	pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8	Apparent terminal elimination half-life is the time measured for the plasma concentration of PF-04856883 to decrease by one-half of its initial concentration.
Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1	pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1	AUC(0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It was calculated as AUC (0-t) plus (last measurable concentration divided by apparent terminal elimination rate constant).

Trial Locations

Locations (2)

Cetero Research; 🇺🇸 Miami Gardens, Florida, United States

Cetero Research - San Antonio; 🇺🇸 San Antonio, Texas, United States