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A Study of the Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of PF-05180999 In Healthy Adults

Pfizer logo

Pfizer

Status and phase

Terminated
Phase 1

Conditions

Migraine

Treatments

Drug: PF-05180999
Drug: 10 mg cetirizine
Drug: Placebo
Drug: 120 mg MR PF-05180999
Drug: 360 mg MR PF-05180999

Study type

Interventional

Funder types

Industry

Identifiers

NCT01981499
B3441009

Details and patient eligibility

About

PF-05180999 is a phosphodiesterase-2 inhibitor that is hypothesized to be able to reduce vascular permeability. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and effects on histamine-induced wheal of single doses of PF-05180999 in healthy adult subjects. Histamine-induced wheals are biomarkers of vascular permeability.

Enrollment

31 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male subjects between the ages of 18 and 55 years
  • No history of clinically-relevant atopic or dermatological disease
  • Positive reaction to intradermal injection of histamine

Exclusion criteria

  • Subjects with screening laboratory test results that deviate from the upper and/or lower limits of the reference or acceptable range. The exception is that all liver function tests must not exceed the upper limit of normal.
  • Subjects with evidence of, or history of, hepatic disorder, including acute or chronic hepatitis B or hepatitis C
  • Intolerance to intradermal histamine injection.
  • Subjects with dark skin (Part B only).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

31 participants in 6 patient groups, including a placebo group

Arm A1
Experimental group
Description:
Part A of study to assess safety, tolerability, and pharmacokinetics of PF-05180999
Treatment:
Drug: PF-05180999
Arm A2
Placebo Comparator group
Description:
Part A of study to assess safety, tolerability, and pharmacokinetics of PF-05180999 relative to placebo
Treatment:
Drug: Placebo
Drug: Placebo
Arm B1
Experimental group
Description:
Part B of study to assess effects of PF-05180999 on histamine-induced wheal
Treatment:
Drug: 120 mg MR PF-05180999
Arm B2
Experimental group
Description:
Part B of study to assess effects of PF-05180999 on histamine-induced wheal
Treatment:
Drug: 360 mg MR PF-05180999
Arm B3
Experimental group
Description:
Positive control to ensure histamine-induced wheal assay integrity
Treatment:
Drug: 10 mg cetirizine
Arm B4
Experimental group
Description:
Placebo control
Treatment:
Drug: Placebo
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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