Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01365624
First received: June 1, 2011
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

This study had an open-label, single-dose design. All subjects received a single dose of 30 mg of intranasal ketorolac. Blood samples for determination of ketorolac plasma levels were obtained pre-dose and at specified time points over 24 hours post-dose.

The primary objective of this trial was to compare the pharmacokinetics of intranasal ketorolac between elderly and nonelderly adult subjects. The secondary objective was to evaluate the safety profile of intranasal ketorolac in elderly subjects.


Condition Intervention Phase
Healthy Subjects
Drug: Ketorolac tromethamine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Cmax (Maximum Plasma Concentration) [ Time Frame: Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose ] [ Designated as safety issue: No ]
  • Tmax (Time to Reach Maximum Plasma Concentration) [ Time Frame: Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose ] [ Designated as safety issue: No ]
  • AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose [ Time Frame: Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose ] [ Designated as safety issue: No ]
  • AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity [ Time Frame: Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose ] [ Designated as safety issue: No ]
  • t1/2z (Terminal Half-life) [ Time Frame: Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose ] [ Designated as safety issue: No ]
  • MRT (Mean Residence Time) [ Time Frame: Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2008
Study Completion Date: July 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketorolac tromethamine Drug: Ketorolac tromethamine
Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The elderly population consisted of male or female volunteers aged > of = 65 years
  • The nonelderly adult population consisted of male or female volunteers aged < 65 years
  • Generally good health in the opinion of the Investigator, as determined by a prestudy physical examination with no clinically significant abnormalities for age, vital signs within normal ranges or outside normal range but not deemed clinically significant for age in the opinion of the Investigator, and no clinically significant electrocardiogram (ECG) abnormalities for age
  • Bilaterally patent nasal airways at screening as assessed by the Investigator
  • Body mass index (BMI) 15-30 kg/m2
  • Female subjects of childbearing potential must consent to use a medically acceptable method of contraception (oral or implanted contraceptive hormones, condom or diaphragm with spermicidal agent, intrauterine device, or surgical sterilization) throughout the study period
  • Ability to provide written informed consent
  • Prestudy clinical laboratory findings within normal ranges or if outside normal range not deemed clinically significant for age in the opinion of the Investigator

Exclusion Criteria:

  • Allergy or sensitivity to ketorolac or formulation ingredients
  • History of co-existing nasal polyps, NSAID sensitivity, and asthma
  • Allergic reaction to aspirin or other NSAIDs
  • Current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of AEs
  • Use of any prescribed or over-the-counter (OTC) drug in the 72 h prior to entry into the study with the exception of occasional acetaminophen up to 24 h prior to entry
  • Suspicion of rhinitis medicamentosa (chronic daily use of topical decongestants)
  • Use of a monoamine oxidase (MAO) inhibitor in the 14 days prior to study entry
  • Positive serum test for human immunodeficiency virus (HIV) or hepatitis B or C
  • Positive alcohol breath test at screening or on entry into the study
  • Positive urine screen for any nonprescribed drug of abuse at screening or on entry into the study
  • History of cocaine use
  • Blood donation within 30 days of beginning study participation
  • Active peptic ulcer disease or a history of peptic ulcer disease or gastrointestinal bleeding
  • Serum creatinine > 2.0 mg/dL
  • Current tobacco use or a past history of smoking within 5 years of study entry
  • Any other clinically significant medical problem, which in the opinion of the Investigator would interfere with study participation
  • Participation within 30 days of study entry or within 5 times the half-life, whichever is longer, in another investigational drug study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01365624

Locations
United States, Florida
Seaview Research
Miami, Florida, United States, 33126
Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
Study Chair: Lincoln Bynum, MD ICON Developmental Solutions
  More Information

No publications provided by Luitpold Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01365624     History of Changes
Other Study ID Numbers: ROX 2007-02
Study First Received: June 1, 2011
Results First Received: August 2, 2012
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014