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

NCT ID: NCT01363089

Last Updated: 2017-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-02-29

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketorolac tromethamine

Group Type: EXPERIMENTAL

Ketorolac tromethamine

Intervention Type: DRUG

30 mg of intranasal ketorolac tromethamine (one 100 µL spray into each nostril of a 15%, pH 7.2 solution)

Oxymetazoline hydrochloride

Group Type: EXPERIMENTAL

Oxymetazoline hydrochloride

Intervention Type: DRUG

Single intranasal dose of oxymetazoline hydrochloride (Afrazine®) (3 sprays of a 0.05% solution into each nostril) followed 30 minutes later by 30 mg of intranasal ketorolac tromethamine (one 100 µL spray into each nostril of a 15%, pH 7.2 solution)

Interventions

Ketorolac tromethamine

30 mg of intranasal ketorolac tromethamine (one 100 µL spray into each nostril of a 15%, pH 7.2 solution)

Intervention Type: DRUG

Oxymetazoline hydrochloride

Single intranasal dose of oxymetazoline hydrochloride (Afrazine®) (3 sprays of a 0.05% solution into each nostril) followed 30 minutes later by 30 mg of intranasal ketorolac tromethamine (one 100 µL spray into each nostril of a 15%, pH 7.2 solution)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Egalet Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cyril Clarke, BSc MB BS MFPM

Role: PRINCIPAL_INVESTIGATOR

ICON Development Solutions

Locations

ICON Development Solutions

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

ROX 2006-03

Identifier Type: -

Identifier Source: org_study_id