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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365624
• Other study ID #: ROX 2007-02
• Status: Completed
• Phase: Phase 1
• First received: June 1, 2011
• Last updated: January 3, 2013
• Start date: February 2008
• Est. completion date: July 2008

Study information

• Verified date: January 2013
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
United States	Seaview Research	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No