A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626976
• Other study ID #: B5211001
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2012
• Last updated: March 12, 2013
• Start date: June 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This is the first-in-human study for an oral investigational compound, PF-06282999, in order to assess its safety, tolerability and pharmacokinetics in humans across a wide range of dose levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

• Women must be of non-childbearing potential.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of =1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06282999
Solution, doses range from 20 to 200 mg, single dose
• Placebo
Solution, single dose
• PF-06282999
Methylcellulose suspension, doses range 125 to 500 mg, single dose
• Placebo
suspension, single dose
• PF-06282999
Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
• Placebo
suspension, single dose
• PF-06282999
Methylcellulose or simethicone suspension, 500 mg dose, single dose
• Placebo
suspension, single dose
• PF-06282999
Simethicone or methylcellulose suspension, up to 1500 mg, single dose
• Placebo
suspension, single dose

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]		0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose	No
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose	No
Primary	Area Under the Curve From Time Zero to 24 hour [AUC24]		0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose	No
Primary	Maximum Observed Plasma Concentration (Cmax)		0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose	No
Primary	Apparent Oral Clearance (CL/F)		0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose	No
Primary	Plasma Decay Half-Life (t1/2)		0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose	No
Primary	Apparent Volume of Distribution (Vz/F)		0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose	No
Primary	Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24)		0 to 24 hours post-dose	No
Primary	Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%)		0 to 24 hours post-dose	No
Primary	Renal Clearance (CLr)		0 to 24 hours post-dose	No
Primary	Oral temperature		0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose	No

External Links

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