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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

June 1, 2011
January 3, 2013
February 2008
April 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Cmax (Maximum plasma concentration) [ Time Frame: Blood samples for PK analyses were obtained at pre-dose (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 (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 (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 (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 ]
  • t1/2/z (Terminal half-life) [ Time Frame: Blood samples for PK analyses were obtained at pre-dose (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 (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 ]
Complete list of historical versions of study NCT01365624 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects
A Phase 1 Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Subjects
Drug: Ketorolac tromethamine
Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
Experimental: Ketorolac tromethamine
Intervention: Drug: Ketorolac tromethamine
Bullingham R, Juan A. Comparison of intranasal ketorolac tromethamine pharmacokinetics in younger and older adults. Drugs Aging. 2012 Nov;29(11):899-904. doi: 10.1007/s40266-012-0023-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01365624
ROX 2007-02
No
Luitpold Pharmaceuticals
Luitpold Pharmaceuticals
Not Provided
Study Chair: Lincoln Bynum, MD ICON Developmental Solutions
Luitpold Pharmaceuticals
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP