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

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ClinicalTrials.gov Identifier: NCT01262690
Recruitment Status : Terminated (The study was terminated on 21-Sept-2011 due to the emergent safety concern of sensory symptoms.)
First Posted : December 17, 2010
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Cachexia Drug: PF-05230901 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : November 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Incidence and severity of adverse events. [ Time Frame: 35 days ]
  2. Incidence and severity of clinical laboratory abnormalities. [ Time Frame: 35 days ]
  3. Mean change from baseline in vital signs. [ Time Frame: 35 days ]
  4. Mean change from baseline in 12-lead electrocardiogram (ECG) parameters. [ Time Frame: 35 days ]
  5. Incidence and severity of findings during the neurological examination. [ Time Frame: 35 days ]

Secondary Outcome Measures :
  1. Plasma concentrations [ Time Frame: 14 days ]
  2. Anti-drug antibodies [ Time Frame: 35 days ]
  3. Appetite and food consumption [ Time Frame: 13 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01262690     History of Changes
Other Study ID Numbers: B2291001
TAM-163 FIH Study; 3279K1-1000
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

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

Additional relevant MeSH terms:
Cachexia
Wasting Syndrome
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders