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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014