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

This study has been terminated.
(The study was terminated on 21-Sept-2011 due to the emergent safety concern of sensory symptoms.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01262690
First received: November 23, 2010
Last updated: October 11, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Cachexia
Drug: PF-05230901
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence and severity of adverse events. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
  • Incidence and severity of clinical laboratory abnormalities. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
  • Mean change from baseline in vital signs. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
  • Mean change from baseline in 12-lead electrocardiogram (ECG) parameters. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
  • Incidence and severity of findings during the neurological examination. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentrations [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Anti-drug antibodies [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
  • Appetite and food consumption [ Time Frame: 13 days ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose
6 treated, 3 placebos
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.
Other Name: TAM-153
Drug: PF-05230901
Single dose SC
Other Name: TAM-163

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262690

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01262690     History of Changes
Other Study ID Numbers: B2291001, TAM-163 FIH Study; 3279K1-1000
Study First Received: November 23, 2010
Last Updated: October 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
First-in-human (FIH)
Single Ascending Dose (SAD) Study
TAM-163
PF-05230901
Cachexia

Additional relevant MeSH terms:
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 14, 2014