First in Human Study for PF-06667272

NCT03126149 | Completed Phase 1 FDA Drug

• 2 other identifiers: C02310022017-000590-36
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The current study is the first clinical trial proposed with PF-06667272. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending doses of PF-06667272 under fed and fasted conditions, in healthy adult subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) or other safety concerns

  Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.

  Baseline (Day 1, hour 0) up to 28 days after last dose of study medication

Secondary Outcomes (7)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06667272 and PF-06818073

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06667272 and PF-06818073 (as permitted)

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose

• Maximum Observed Plasma Concentration (Cmax) for PF-06667272 and PF-06818073

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose

• Time to Reach Maximum Observed Concentration for PF-06667272 and PF-06818073

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose

• Plasma Decay Half-Life (t1/2) for PF-06667272 and PF-06818073

  0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post dose

Study Arms (16)

Cohort 1_Period 1_Active

EXPERIMENTAL

Single ascending dose of PF-06667272

Drug: PF-06667272

Cohort 1_Period 1_Placebo

PLACEBO COMPARATOR

Single dose of placebo

Other: Placebo

Cohort 1_Period 2_Active

EXPERIMENTAL

Single ascending dose of PF-06667272

Drug: PF-06667272

Cohort 1_Period 2_Placebo

PLACEBO COMPARATOR

Single dose of placebo

Other: Placebo

Cohort 1_Period 3_Active

EXPERIMENTAL

Single ascending dose of PF-06667272

Drug: PF-06667272

Cohort 1_Period 3_Placebo

PLACEBO COMPARATOR

Single dose of placebo

Other: Placebo

Cohrot 1_Period 4_Active

EXPERIMENTAL

Single ascending dose of PF-06667272

Drug: PF-06667272

Cohort 1_Period 4_Placebo

PLACEBO COMPARATOR

Single dose of placebo

Other: Placebo

Cohort 2_Period 1_Active

EXPERIMENTAL

Single ascending dose of PF-06667272

Drug: PF-06667272

Cohort 2_Period 1_Placebo

PLACEBO COMPARATOR

Single dose of placebo

Other: Placebo

Cohort 2_Period 2_Active

EXPERIMENTAL

Single ascending dose of PF-06667272

Drug: PF-06667272

Cohort 2_Period 2_Placebo

PLACEBO COMPARATOR

Single dose of placebo

Other: Placebo

Cohort 2_Period 3_Active

EXPERIMENTAL

Single ascending dose of PF-06667272

Drug: PF-06667272

Cohort 2_Period 3_Placebo

PLACEBO COMPARATOR

Single dose of placebo

Other: Placebo

Cohort 2_Period 4_Active

EXPERIMENTAL

Single ascending dose of PF-06667272

Drug: PF-06667272

Cohort 2_Period 4_Placebo

PLACEBO COMPARATOR

Single dose of placebo

Other: Placebo

Interventions

PF-06667272 DRUG

Single ascending dose of PF-06667272

Cohort 1_Period 1_Active; Cohort 1_Period 2_Active; Cohort 1_Period 3_Active; Cohort 2_Period 1_Active; Cohort 2_Period 2_Active; Cohort 2_Period 3_Active; Cohort 2_Period 4_Active; Cohrot 1_Period 4_Active

Placebo OTHER

Single dose of placebo

Cohort 1_Period 1_Placebo; Cohort 1_Period 2_Placebo; Cohort 1_Period 3_Placebo; Cohort 1_Period 4_Placebo; Cohort 2_Period 1_Placebo; Cohort 2_Period 2_Placebo; Cohort 2_Period 3_Placebo; Cohort 2_Period 4_Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and female of non-childbearing potential;
• Body Mass Index 17.5-30.5 kg/m2;
• Body weight \>50 kg;

You may not qualify if:

• Evidence of 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 24, 2017
• Study Start: May 11, 2017
• Primary Completion: September 5, 2017
• Study Completion: September 5, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)