Phase 1 N=84 Randomized Double-blind Basic Science

A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT02211261 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Oct 2018

Primary outcome: Primary: Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events — 5; 3; 3; 5 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: PF-06293620 (Biological); Placebo (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events	5; 3; 3; 5; 5; 0	—
PRIMARY Number of Participants With Dose Limiting or Intolerable Adverse Events	—	—
PRIMARY Number of Participants With Positive Anti-drug Antibody (ADA) Result	1; 5; 2; 1; 2; 0	—
SECONDARY Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)	300; 1716; 6306; 19440; 6775	—
SECONDARY Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)	12.00; 22.24; 23.79; 36.13; 67.94	—
SECONDARY Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)	128.3; 1619; 5945; 18080; 6509	—
SECONDARY Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)	4.779; 21.01; 22.47; 33.59; 65.26	—
SECONDARY Clearance (CL) of PF-06293620 (SAD Cohorts)	14.72	—
SECONDARY Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)	83.20; 44.93; 42.05; 27.67	—
SECONDARY Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)	0.3907; 2.896; 7.222; 22.30; 27.64	—
SECONDARY Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)	168; 168; 252; 168; 1.00	—
SECONDARY Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)	7.095	—
SECONDARY Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)	21.10; 16.25; 20.63; 18.17	—
SECONDARY Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)	7.33; 10.95; 14.66; 19.23; 14.37	—
SECONDARY Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration	609.6; 802.5; 2752; 1309; 2991; 6121	—
SECONDARY Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration	1.526; 1.706; 5.184; 1.989; 6.012; 11.74	—
SECONDARY Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration	0.9067; 1.194; 4.096; 1.948; 4.449; 9.102	—
SECONDARY Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration	0.7555; 1.979; 5.456	—
SECONDARY Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration	240; 252; 360; 168; 144; 120	—
SECONDARY Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration	38.19; 25.07; 24.53	—
SECONDARY Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration	13.43; 10.45; 12.09	—
SECONDARY Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration	10.37; 12.72; 14.50	—
SECONDARY Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)	1.833; 3.446; 2.148	—
SECONDARY Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)	1.302; 3.257; 2.188	—

Summary

A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus

Eligibility Criteria

Inclusion Criteria

Men and women of non-childbearing potential with Type 2 Diabetes Mellitus
Subjects on stable doses of metformin >/= 1500 mg daily (SAD cohorts) or >/= 1000 mg daily (MAD cohorts) x 30 days prior to screening
HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening
Fasting C-peptide >1.12 ng/mL (SAD cohorts) or >/= 0.8 mg/mL (MAD cohorts) at screening

Exclusion Criteria

History of Type 1 diabetes mellitus
Evidence of diabetic complications with significant end-organ damage
History of chronic pancreatitis or at high risk for pancreatitis
Poorly controlled hypertension
History of cardiovascular or cerebrovascular event or procedure

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02211261). 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.