| First In Human Study Of Increasing Oral Doses Of PF-04634817 |
| A Double Blind, Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Pharmacokinetics (In The Fed And Fasted State), Safety And Toleration Of Single Oral Doses Of PF-04634817 In Healthy Volunteers |
| The study will evaluate the hypothesis that at doses and plasma concentrations which affect pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic profile is robust and consistent with a once or twice a day therapeutic administration. |
| Not Provided |
| Interventional |
| Phase 1 |
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
| Healthy |
- Drug: PF-04634817 Placebo
Oral solution, placebo, single dose
- Drug: PF-04634817
Oral solution, 1mg, single dose
- Drug: PF-04634817
Oral solution, 3mg, single dose
- Drug: PF-04634817
Oral solution, 10mg, single dose
- Drug: PF-04634817
Oral solution, 30mg, single dose
- Drug: PF-04634817
Oral solution, 100mg, single dose
- Drug: PF-04634817
Oral solution, 300mg, single dose
- Drug: PF-04634817
Oral solution, 600mg, single dose
- Drug: PF-04634817
Oral solution, 900mg, single dose
- Drug: PF-04634817
Oral solution, up to 900mg, single dose after food
- Drug: PF-04634817 Placebo
Oral solution, placebo, single dose after food
|
- Placebo Comparator: Placebo
Intervention: Drug: PF-04634817 Placebo
- Experimental: Cohort 1, 1mg
Intervention: Drug: PF-04634817
- Experimental: Cohort 1, 3mg
Intervention: Drug: PF-04634817
- Experimental: Cohort 1, 10mg
Intervention: Drug: PF-04634817
- Experimental: Cohort 2, 30mg
Intervention: Drug: PF-04634817
- Experimental: Cohort 2, 100mg
Intervention: Drug: PF-04634817
- Experimental: Cohort 2, 300mg
Intervention: Drug: PF-04634817
- Experimental: Cohort 3, 600mg
Intervention: Drug: PF-04634817
- Experimental: Cohort 3, 900mg
Intervention: Drug: PF-04634817
- Experimental: Cohort 3, up to 900mg (fed)
Intervention: Drug: PF-04634817
- Placebo Comparator: Cohort 3, placebo (fed)
Intervention: Drug: PF-04634817 Placebo
|
| Not Provided |
| |
| Completed |
| 27 |
| September 2010 |
| September 2010 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Healthy male or female (of non-child bearing potential) subjects between 18 and 55 years of age.
- Body mass index of 17.5 to 30.5 kg/m2 and total body weight > 50kg.
Exclusion Criteria:
- Evidence or history of any clinically significant disease.
- Treatment with an investigational drug within 30 days of study start
- Use of prescription and non-prescription medicines within 7 days of study start
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 55 Years (Adult) |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| |
| NCT01098877 |
| B1261002 |
| No |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| October 2010 |
