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

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: Ketorolac tromethamine

Registration Number: NCT01365624

Lead Sponsor: American Regent, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketorolac tromethamine	Ketorolac tromethamine	-

Primary Outcome Measures

Name	Time	Method
Cmax (Maximum Plasma Concentration)	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
Tmax (Time to Reach Maximum Plasma Concentration)	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
AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose	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
AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity	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
t1/2z (Terminal Half-life)	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
MRT (Mean Residence Time)	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