Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGKetorolac tromethamine
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
Sponsors
Egalet Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort Measurement on a Visual Analogue Scale | 15 minutes post-dose | Following administration of each treatment, subjects completed a visual analogue scale (VAS) (ranging from no discomfort to severe discomfort) at 1, 5, 10 and 15 minutes post-dose. If after the 15 minute VAS assessment discomfort was still present the subject was asked to complete further VAS assessments, at 5 minute intervals, until the discomfort had dissipated. |
Countries
United Kingdom
Outcome results
None listed