Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine

• ClinicalTrials.gov Identifier: NCT00520169
• Recruitment Status: Completed
• First Posted: August 23, 2007
• Last Update Posted: January 10, 2008
• Sponsor: Javelin Pharmaceuticals
• Information provided by: Javelin Pharmaceuticals

Tracking Information

• First Submitted Date: August 21, 2007
• First Posted Date: August 23, 2007
• Last Update Posted Date: January 10, 2008
• Study Start Date: July 2007
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 9, 2008): ketamine pharmacokinetics [ Time Frame: multiple ]
• Original Primary Outcome Measures (submitted: August 22, 2007): ketamine pharmacokinetics
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine
• Official Title: A Randomized, Open Label, Single Center, Single-Dose, Cross-Over Study to Determine the Absolute Bioavailability and the Nasopharyngeal Absorption of PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers
• Brief Summary: This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.
• Detailed Description: To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy

Intervention

Drug: intranasal ketamine

A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.

Study Arms

• Active Comparator: A
  oral ketamine
  Intervention: Drug: intranasal ketamine
• Experimental: B
  intranasal ketamine
  Intervention: Drug: intranasal ketamine
• Active Comparator: C
  intravenous ketamine
  Intervention: Drug: intranasal ketamine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 22, 2007): 32
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2007
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy adults

Exclusion Criteria:

• under 18 years

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00520169
• Other Study ID Numbers: KET-PK-007
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Javelin Pharmaceuticals
• Original Responsible Party: Not Provided
• Current Study Sponsor: Javelin Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Javelin Pharmaceuticals; Javelin Pharmaceuticals

• PRS Account: Javelin Pharmaceuticals
• Verification Date: January 2008