| A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers |
| A Phase 1, Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Ascending Dose Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Subjects |
| The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers. |
| Not Provided |
| Interventional |
| Phase 1 |
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science |
| Healthy |
- Biological: PF-05230907
0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose
- Drug: Placebo for PF-05230907
0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
- Biological: PF-05230907
0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose
- Drug: Placebo for PF-05230907
0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
- Biological: PF-05230907
1 micrograms per kilogram of PF-05230907, IV bolus, single dose
- Drug: Placebo for PF-05230907
1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
- Biological: PF-05230907
2 micrograms per kilogram of PF-05230907, IV bolus, single dose
- Drug: Placebo for PF-05230907
2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
- Biological: PF-05230907
3 micrograms per kilogram of PF-05230907, IV bolus, single dose
- Drug: Placebo for PF-05230907
3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
- Biological: PF-05230907
5 micrograms per kilogram of PF-05230907, IV bolus, single dose
- Drug: Placebo for PF-05230907
5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
|
- Experimental: PF-05230907 and Placebo Cohort 1
Interventions:
- Biological: PF-05230907
- Drug: Placebo for PF-05230907
- Experimental: PF-05230907 and Placebo Cohort 2
Interventions:
- Biological: PF-05230907
- Drug: Placebo for PF-05230907
- Experimental: PF-05230907 and Placebo Cohort 3
Interventions:
- Biological: PF-05230907
- Drug: Placebo for PF-05230907
- Experimental: PF-05230907 and Placebo Cohort 4
Interventions:
- Biological: PF-05230907
- Drug: Placebo for PF-05230907
- Experimental: PF-05230907 and Placebo Cohort 5
Interventions:
- Biological: PF-05230907
- Drug: Placebo for PF-05230907
- Experimental: PF-05230907 and Placebo Cohort 6
Interventions:
- Biological: PF-05230907
- Drug: Placebo for PF-05230907
|
| Not Provided |
| |
| Completed |
| 49 |
| March 2015 |
| March 2015 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Healthy male subjects.
- Healthy non-child bearing female subjects.
- 18 to 35 years of age.
Exclusion Criteria:
- Heart disease.
- Clotting disorders.
- Use of nicotine products.
- Diabetes.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 35 Years (Adult) |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium |
| |
| |
| NCT01897142 |
B2341001
2013-001387-36 ( EudraCT Number ) |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| April 2016 |
