Study to Assess the PK of Ketorolac Tromethamine Intranasal and to Assess the Effects of a Oxymetazoline Hydrochloride on the PK of Ketorolac Tromethamine

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

This was an open label, two way crossover study in healthy male subjects. Two treatments were administered to each subject, one treatment per study period, in a randomized manner. Subjects remained resident in the Clinical Unit from the evening of Day 1 until the morning of Day 2 of each period and there was a washout period of at least 2 days between treatments. A post study medical examination was performed prior to discharge in Period 2.

The objective of this study was to assess the effects of a single dose of intranasal oxymetazoline hydrochloride on the pharmacokinetics of intranasal ketorolac in healthy male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Egalet Ltd; Luitpold Pharmaceuticals
• Treatments: Ketorolac; Ketorolac Tromethamine; Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

• Subject was male and aged 18 to 62 years inclusive

• 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, intrauterine device or surgical sterilization plus condom or diaphragm with spermicidal agent) throughout the study period

• Subject had given signed informed consent

• Subject was within 20% of normal weight for his 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 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

• Subject had a body weight of at least 60 kg

Exclusion Criteria:

• Subject had had a clinically significant illness in the 4 weeks before screening

• Subject used prescribed medications in the 3 weeks prior to dosing or over the counter preparations for 7 days prior to dosing, except paracetamol which was allowed up to 48 hours (h) prior to dosing. Use of multivitamins was 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

• Subject currently used tobacco or had a history of smoking within the past 5 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 3 months prior to dosing

• Subject had a positive human immunodeficiency virus (HIV), hepatitis B 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 3 months prior to screening

• Subject had any history of co-existing nasal polyps, NSAID sensitivity and asthma

• Subject had an allergic reaction to aspirin or other NSAIDs

• Subject currently had an 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

• Subject had any suspicion of rhinitis medicamentosa (chronic daily use of topical decongestants)

• Subject had used a monoamine oxidase inhibitor in the 14 days prior to study entry

• Subject had an active peptic ulcer disease, gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding

• Subject had anemia due to unexplained or known gastrointestinal bleeding

• Subject had a history of asthma or any other chronic pulmonary disorder

• Subject had renal impairment or a risk of renal failure due to volume depletion

• Subject had a previous history of nasal surgery