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First in Human Study for PF-06667272

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: PF-06667272
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03126149
C0231002
2017-000590-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

16 participants in 16 patient groups, including a placebo group

Cohort 1_Period 1_Active
Experimental group
Description:
Single ascending dose of PF-06667272
Treatment:
Drug: PF-06667272
Cohort 1_Period 1_Placebo
Placebo Comparator group
Description:
Single dose of placebo
Treatment:
Other: Placebo
Cohort 1_Period 2_Active
Experimental group
Description:
Single ascending dose of PF-06667272
Treatment:
Drug: PF-06667272
Cohort 1_Period 2_Placebo
Placebo Comparator group
Description:
Single dose of placebo
Treatment:
Other: Placebo
Cohort 1_Period 3_Active
Experimental group
Description:
Single ascending dose of PF-06667272
Treatment:
Drug: PF-06667272
Cohort 1_Period 3_Placebo
Placebo Comparator group
Description:
Single dose of placebo
Treatment:
Other: Placebo
Cohrot 1_Period 4_Active
Experimental group
Description:
Single ascending dose of PF-06667272
Treatment:
Drug: PF-06667272
Cohort 1_Period 4_Placebo
Placebo Comparator group
Description:
Single dose of placebo
Treatment:
Other: Placebo
Cohort 2_Period 1_Active
Experimental group
Description:
Single ascending dose of PF-06667272
Treatment:
Drug: PF-06667272
Cohort 2_Period 1_Placebo
Placebo Comparator group
Description:
Single dose of placebo
Treatment:
Other: Placebo
Cohort 2_Period 2_Active
Experimental group
Description:
Single ascending dose of PF-06667272
Treatment:
Drug: PF-06667272
Cohort 2_Period 2_Placebo
Placebo Comparator group
Description:
Single dose of placebo
Treatment:
Other: Placebo
Cohort 2_Period 3_Active
Experimental group
Description:
Single ascending dose of PF-06667272
Treatment:
Drug: PF-06667272
Cohort 2_Period 3_Placebo
Placebo Comparator group
Description:
Single dose of placebo
Treatment:
Other: Placebo
Cohort 2_Period 4_Active
Experimental group
Description:
Single ascending dose of PF-06667272
Treatment:
Drug: PF-06667272
Cohort 2_Period 4_Placebo
Placebo Comparator group
Description:
Single dose of placebo
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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