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

Egalet

Status and phase

Completed

Phase 1

Conditions

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

Treatments

Drug: Oxymetazoline hydrochloride

Drug: Ketorolac tromethamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01363089

ROX 2006-03

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

Male

Ages

18 to 62 years old

Volunteers

Accepts Healthy Volunteers

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