A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin

Cachexia Clinical Trial

Official title:

A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01262690
• Other study ID #: B2291001
• Secondary ID: TAM-163 FIH Stud
• Status: Terminated
• Phase: Phase 1
• First received: November 23, 2010
• Last updated: October 11, 2011
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will examine whether a single dose of PF-05230901 is safe and well tolerated when given to healthy volunteers by injection under the skin. An additional objective is to measure the blood concentrations of PF-05230901. Each dose will be tested in a different group of subjects starting from the lowest dose.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

• History of seizures, including childhood seizures.

• History of movement disorders or related neurological conditions.

• History of head trauma associated with loss of consciousness.

Study Design

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

Related Conditions & MeSH terms

• Cachexia

Intervention

Drug:
• PF-05230901
Single ascending doses of PF-05230901 in separate cohorts of subjects; each cohort consists of 6 subjects treated with PF-05230901 and 3 subjects treated with placebo.
• PF-05230901
Single dose SC

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events.		35 days	Yes
Primary	Incidence and severity of clinical laboratory abnormalities.		35 days	Yes
Primary	Mean change from baseline in vital signs.		35 days	Yes
Primary	Mean change from baseline in 12-lead electrocardiogram (ECG) parameters.		35 days	Yes
Primary	Incidence and severity of findings during the neurological examination.		35 days	Yes
Secondary	Plasma concentrations		14 days	Yes
Secondary	Anti-drug antibodies		35 days	Yes
Secondary	Appetite and food consumption		13 days	No

External Links

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