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

NCT ID: NCT01365624

Last Updated: 2013-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2008-07-31

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketorolac tromethamine

Group Type: EXPERIMENTAL

Ketorolac tromethamine

Intervention Type: DRUG

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

Interventions

Ketorolac tromethamine

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Regent, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lincoln Bynum, MD

Role: STUDY_CHAIR

ICON Developmental Solutions

Locations

Seaview Research

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23143939 (View on PubMed)

Other Identifiers

ROX 2007-02

Identifier Type: -

Identifier Source: org_study_id