Study of the Tolerability of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers

Egalet

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Ketorolac tromethamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01363063

ROX 2006-01

Details and patient eligibility

About

This was a Phase 1, double blind, two part study in healthy male and female volunteers. Each subject participated in only one part of the study. In Part A subjects received one dose of 15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the other nostril, in a randomized manner. In Part B subjects were randomized to receive a single intranasal dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride into one nostril and either placebo or a single intranasal dose of 15 mg ketorolac tromethamine containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril. During the study, subjects remained resident from the morning of Day 1 until the afternoon of Day 1, when a post-study medical was performed prior to discharge.

The objective of this study was to compare the tolerability of formulations of ketorolac tromethamine with differing concentrations of lidocaine hydrochloride (0% and 6% in Part A and 0%, 4%, 6% and placebo in Part B) following intranasal administration to healthy volunteers.

Enrollment

40 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female volunteers, aged 18 to 60 years inclusive
Female subjects of child bearing potential must have had a negative urine pregnancy test prior to entry into the study and must not have been breast feeding
All female subjects of child bearing potential and all male subjects with female partners of child bearing potential must have consented 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
Subject had given signed informed consent
Subject was within 20% of normal weight for his/her height and body build according to the table of "Desirable Weights for Men and Women" (Metropolitan Life Insurance Co. 1999)
Subject's medical history was considered normal, with no clinically significant abnormalities
Subject was considered to be in good health in the opinion of the Investigator, as determined by a pre-study physical examination with no clinically significant abnormalities, vital signs within normal ranges and an electrocardiogram (ECG) with no clinically significant abnormalities
Subject's pre-study clinical laboratory findings were within the normal range or if outside of the normal range were not deemed clinically significant in the opinion of the Investigator
Subject had bilateral patent nasal airways at screening and Day 1 as assessed by the Investigator
Body weight of at least 60 kg

Exclusion criteria

Subject had had a clinically significant illness in the four weeks before screening
Use of prescribed medications in the three weeks prior to dosing or over-the-counter preparations for seven days prior to dosing, except paracetamol which was allowed up to 48 hours prior to dosing. However, use of multivitamins and oral contraceptives were permitted
Subject had a significant history of drug/solvent abuse, or a positive drugs of abuse test at screening
Subject had a history of alcohol abuse or currently drank in excess of 28 units per week (males) or 21 units per week (females)
Current tobacco use or a history of smoking within the past five years
Subject was in the opinion of the Investigator not suitable to participate in the study
Subject had participated in any clinical study with an investigational drug/device within three months prior to dosing
Subject had a positive result of human immunodeficiency virus (HIV) screen, Hepatitis B screen or Hepatitis C screen
Subject had had a serious adverse reaction or significant hypersensitivity to any drug
Subject had donated 500 mL or more of blood within the three months prior to screening
Any 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 have interfered with the absorption of the nasal spray or with the assessment of adverse events (AEs)
Any suspicion of rhinitis medicamentosa (chronic daily use of topical decongestants)
Use of a monoamine oxidase inhibitor in the 14 days prior to study entry
Active peptic ulcer disease, gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding
Anemia due to unexplained or known gastrointestinal bleeding
History of asthma or any other chronic pulmonary disorder
Renal impairment or a risk of renal failure due to volume depletion
Known sensitivity to lidocaine hydrochloride
Previous history of nasal surgery