Overview

This trial has been completed.

Condition diabetes mellitus, type 1
Treatments placebo, pf-06342674 dose a, pf-06342674 dose b, pf-06342674 dose c, pf-06342674 dose d
Phase phase 1
Sponsor Pfizer
Start date June 2014
End date September 2016
Trial size 37 participants
Trial identifier NCT02038764, B4351003

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Placebo Comparator)
Placebo
placebo
Placebo
(Experimental)
pf-06342674 dose a
Multiple SC Doses
pf-06342674 dose b
Multiple SC Doses
pf-06342674 dose c
Multiple SC Doses
pf-06342674 dose d
Multiple SC Doses

Primary Outcomes

Measure
Incidence of dose limiting or intolerable treatment related AEs
time frame: 127 days
Incidence of treatment emergent AEs
time frame: 127 days
Incidence and severity of hypoglycemic events
time frame: 127 days
Incidence of abnormal laboratory findings
time frame: 127 days
Vital signs
time frame: 127 days
Incidence of anti-drug antibodies
time frame: 127 days
Severity of treatment emergent AEs
time frame: 127 days
Causal relationship of treatment emergent AEs
time frame: 127 days
Blood pressure
time frame: 127 days
ECG parameters
time frame: 127 days

Secondary Outcomes

Measure
Area under the Concentration-Time Curve (AUC)
time frame: 127 days
Apparent Oral Clearance (CL/F)
time frame: 127 days
Maximum Observed Plasma Concentration (Cmax)
time frame: 127 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
time frame: 127 days
Plasma Decay Half-Life (t1/2)
time frame: 127 days
Volume of Distribution at Steady State (Vss)
time frame: 127 days
Accumulation ratio (R)
time frame: 127 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Women and men age 18 and older. - Diagnosis of type 1 diabetes within 2 years of randomization. - Peak stimulated C-peptide levels ≥ 0.15 ng/mL. Exclusion Criteria: - Anticipated ongoing use of diabetes medications other than insulin. - Evidence or history of diabetic complications with significant end-organ damage. - Episode of severe hypoglycemia within 60 days of randomization. - Multiple hospitalizations for diabetic ketoacidosis.

Additional Information

Official title A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Doses Of Pf-06342674 (rn168) In Adults With Type 1 Diabetes
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Pfizer.