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Completed

NCT Number: NCT01365624

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seaview Research

Miami, Florida, 33126, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketorolac Tromethamine

Drug

Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study title

A Phase 1 Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 3, 2011
Registry last updated
Feb 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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