A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897142
• Other study ID #: B2341001
• Secondary ID: 2013-001387-36
• Status: Completed
• Phase: Phase 1
• First received: June 24, 2013
• Last updated: May 1, 2015
• Start date: September 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting treatment related adverse events		Through Day 43	Yes
Primary	Incidence, severity and causal relationship of treatment emergent adverse events, treatment emergent serious adverse events, and withdrawals due to treatment emergent adverse events		Through Day 43	Yes
Primary	Incidence and magnitude of treatment emergent abnormal laboratory findings		Through Day 43	Yes
Primary	Change from baseline in vital sign measurements, ECG parameters, and physical examinations		Through Day 43	Yes
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		Through 4 hour post dose Day 1	No
Secondary	Maximum Observed Plasma Concentration (Cmax)		Through 4 hour post dose Day 1	No
Secondary	Pharmacodynamic activity as measured by prothrombin time/internationalize normalized ration (PT/INR)		Through post dose Day3	No
Secondary	Pharmacodynamic activity as measured by activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT)		Through post dose Day3	No
Secondary	Pharmacodynamic activity as measured by thrombin-antithrombin (TAT) complexes		Through post dose Day 2	No
Secondary	Pharmacodynamic activity as measured by prothrombin fragments 1+2 (PF1+2)		Through post dose Day 2	No
Secondary	Pharmacodynamic activity as measured by D-dimer		Through post dose Day 7	No
Secondary	Pharmacodynamic activity as measured by protein C activity		Through post dose Day 2	No
Secondary	Pharmacodynamic activity as measured by Factor V activity		Through post dose Day 3	No
Secondary	Incidence of antibody immune response		Through post dose Day 43	Yes
Secondary	Factor X activity		Through post dose Day 43	Yes

External Links

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