PF-04634817 Renal Impairment Study

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01791855
• Collaborator: (none)
• Enrollment: 26
• Locations: 2
• Arms: 4
• Duration (Months): 4
• Patients Per Site: 13
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

Patients with renal impairment are the target population for PF-04634817. The clearance mechanism of this drug means that exposure may be increased in subjects with renal impairment. This study will investigate the effect of the drug in subjects with varying degrees of renal impairment. Pharmacokinetics, safety and toleration will be assessed.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency	Drug: PF-04634817; Drug: PF-04634817; Drug: PF-04634817; Drug: PF-04634817	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Single Dose, Open-Label Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04634817
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy Volunteers	Drug: PF-04634817; Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min)
Experimental: Mild Renal Impairment	Drug: PF-04634817; Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min)
Experimental: Moderate renal impairment	Drug: PF-04634817; Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min)
Experimental: Severe renal impairment	Drug: PF-04634817; Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 post dose]

   Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 post dose]

3. Maximum Observed Plasma Concentration (Cmax) [pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 post dose]

4. Apparent Oral Clearance (CL/F) [pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 post dose]

   Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

5. Apparent Volume of Distribution (Vz/F) [pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 post dose]

   Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

6. Plasma Decay Half-Life (t1/2) [pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 post dose]

   Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

7. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] [pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 post dose]

   AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.

8. Area Under the Curve From Time Zero 48 hours[AUC (0 - 48)] [pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 84, 96, 108, 120, 132, 144, 156, 216, 312 post dose]

   AUC (0 - 48)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 48h

Secondary Outcome Measures

1. Urinary Ae48 [0-24, 24-48 post dose]

   Amount of drug excreted unchanged in urine over 48 hours

2. Urinary AE48 (% excreted) [0-24, 24-48 post dose]

   % of drug excreted unchanged in urine over 48 hours

3. Urinary CLR [0-24, 24-48 post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female (non child bearing potential aged 18-75 years

• Documented renal impairment (mild, moderate or severe using Cockcroft-Gault equation) or matched healthy volunteers (age, weight and gender)

Exclusion Criteria:

• Subjects with acute renal failure

• Subjects receiving, or likely to receive, CYP450 3A4 inhibitors

• Abnormal ECG at screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Deland	Florida	United States	32720
2	Pfizer Investigational Site	Miami	Florida	United States	33136

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01791855
• Other Study ID Numbers: B1261008
• First Posted: Feb 15, 2013
• Last Update Posted: Oct 18, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Pfizer: Subjects with Renal Impairment; healthy
• Additional relevant MeSH terms: Renal Insufficiency

Study Results

No Results Posted as of Oct 18, 2013