Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00788294
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 4
• Duration (Months): 7
• Patients Per Site Per Month: 10.9

Study Details

Study Description

Brief Summary

The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Biological: tanezumab; Biological: tanezumab; Biological: tanezumab; Biological: tanezumab	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 10 mg IV	Biological: tanezumab; Drug solution given intravenously only once at dose of 10 mg
Active Comparator: 5 mg SC	Biological: tanezumab; Drug solution given subcutaneously only once at dose of 5 mg.
Active Comparator: 10 mg SC	Biological: tanezumab; Drug solution given subcutaneously only once at dose of 10 mg.
Active Comparator: 19 mg SC	Biological: tanezumab; Drug solution given subcutaneously only once at dose of 19 mg.

Outcome Measures

Primary Outcome Measures

1. Subcutaneous bioavailability [16 weeks]

2. Injection site reactions [16 weeks]

3. Immunogenicity [16 weeks]

Secondary Outcome Measures

1. Nerve growth factor levels [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Generally healthy

• BMI of 18-30 kg/m2

• more than 50 kg bodyweight.

Exclusion Criteria:

• Pregnant

• exposure to biologic type drugs within the last 3 months

• history of allergic or anaphylactic reaction to a biologic drug

• use of tobacco- or nicotine containing products that is more than what is in 5 cigarettes per day

• excessive alcohol use.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Cypress	California	United States	90630

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00788294
• Other Study ID Numbers: A4091013
• First Posted: Nov 10, 2008
• Last Update Posted: Oct 6, 2020
• Last Verified: Jul 1, 2009

• Studies a U.S. FDA-regulated Drug Product: Yes
• Keywords provided by Pfizer: Pharmacokinetics tanezumab subcutaneous bioavailability intravenous Japanese subjects
• Additional relevant MeSH terms: Tanezumab

Study Results

No Results Posted as of Oct 6, 2020