Study to Determine the Tolerability, Safety and Pharmacokinetics of Ketorolac Tromethamine by 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

NCT01363050

ROX 2005-03

Details and patient eligibility

About

This was a phase 1, open label, multiple dose study in healthy male and female volunteers. Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.

The objective of this study in healthy volunteers was to determine the safety, tolerability, and pharmacokinetics of multiple doses of intranasal ketorolac tromethamine.

Enrollment

15 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 were to have 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 using a medically acceptable method of contraception (oral or implanted contraceptive hormones, condom or diaphragm with spermicidal agent, intrauterine device or surgical sterilisation) 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 ECG with no clinically significant abnormalities
Subject's pre-study clinical laboratory findings were within normal range or, if outside of the normal range, not deemed clinically significant in the opinion of the Investigator
Subject had bilateral patent nasal airways at screening as assessed by the Investigator
Body weight of at least 60 kg

Exclusion criteria

Subject had a clinically significant illness in the four weeks prior to 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. 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
Subjects with a history of alcohol abuse or those currently drinking more than 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
Subjects who had participated in any clinical study with an investigational drug/device within three months prior to the first day of dosing
Subjects who had a positive result of HIV screen, Hepatitis B screen or Hepatitis C screen
Subjects who had a serious adverse reaction or significant hypersensitivity to any drug
Subjects having 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 may 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 (MAOI) 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