Clinical trial NCT02292433: A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, 3- Period, Crossover Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Two Dose Levels of Pf-04937319 In Japanese Subjects With Type 2 Diabetes Mellitus as Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Phase 1
type 2 diabetes
monotherapy
PF-04937319
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-11-17
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As Monotherapy


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes, on diet/exercise therapy only or background therapy with 1 oral anti-diabetic agent (excluding Actos)

Exclusion Criteria:

* Patients with cardiovascular event
* Patients with diabetic complications
* Female subjects who are pregnant or planning to become pregnant
* Subjects with unstable medical conditions (eg, hypertension)

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
measure: Number of Participants With Protocol Defined Hypoglycaemic Adverse Events (HAEs)
timeFrame: Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)
measure: Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-04937319
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-04937319
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
measure: Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF-04937319
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post-dose on Day 1
measure: Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF-04937319
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-04937319
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
measure: Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-04937319
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
measure: Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF-04937319
timeFrame: 0 hour (pre-dose) on Day 7
measure: Average Plasma Concentration (Cav) on Day 7 for PF-04937319
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
measure: Apparent Oral Clearance on Day 7 for PF-04937319
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
measure: Terminal Half-Life (t1/2) on Day 7 for PF-04937319
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
measure: Apparent Volume of Distribution on Day 7 for PF-04937319
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
measure: Accumulation Ratio (Rac) on Day 7 for PF-04937319
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-06455349
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-06455349
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
measure: Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF--06455349
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
measure: Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 1
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1
measure: Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF--06455349
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-06455349
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
measure: Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF--06455349
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
measure: Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF--06455349
timeFrame: 0 hour (pre-dose) on Day 7
measure: Average Plasma Concentration (Cav) on Day 7 for PF--06455349
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
measure: Terminal Half-Life (t1/2) on Day 7 for PF-06455349
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7
measure: Accumulation Ratio (Rac) on Day 7 for PF-06455349
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
measure: Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 7
timeFrame: 0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7
measure: Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 7
timeFrame: Pre-morning meal, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours post- morning meal on Day 0; pre-morning dose, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20 hours post-morning dose on Day 7
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Last Day of Treatment
timeFrame: Pre-morning meal on Day 0, pre-morning dose on Day 1, pre-morning dose on Day 7, pre-morning meal on Day 8
measure: Change From Baseline in Pre-Meal Insulin at Day 7
timeFrame: Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7
measure: Change From Baseline in Pre-Meal C-Peptide at Day 7
timeFrame: Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7
Other outcomes:
Locations:
city: Hachioji-shi
country: Japan
facility: P-one Clinic, Keikokai Medical Corporation
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: