A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers

Condition(s) targeted: Healthy

Intervention: Tramadol HCl, 50 mg (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Janssen Scientific Affairs, LLC

Official(s) and/or principal investigator(s):
Janssen Scientific Affairs, LLC Clinical trial, Study Director, Affiliation: Janssen Scientific Affairs, LLC

The purpose of this study is to determine the safety and tolerability profile of tramadol hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported by currently available toxicology and clinical data (200 mg to 600 mg per day).

Official title: A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics Following Multiple Ascending Doses of Tramadol Hydrochloride in Healthy Male and Female Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from baseline in vital signs and other parameters as a measure of safety and tolerability of tramadol

Secondary outcome:

Change from baseline in time-matched electrocardiogram (ECG) measurements

Change from baseline in pharmacokinetic parameters of tramadol and M1 metabolite

Incidence and type of adverse events

Detailed description: This is a randomized (study drug assigned by chance), sequential-cohort (time lagged), double-blind (neither the participant or the study doctor will know the name of the assigned treatment), parallel-group, placebo-controlled, 3-arm (participants will be assigned to 1 of 3 treatment groups), single-center, Phase 1 study of multiple ascending doses of tramadol HCl in healthy adult volunteers. Thirty participants (15 men and 15 women) will be sequentially assigned to 1 of 3 treatment groups of 10 subjects each (5 men and 5 women). Participants in each treatment group will receive a total of 9 oral doses (one every 6 hours) of tramadol HCl or placebo, in the ratio of 4: 1. The study includes a screening phase and a double-blind treatment phase. The treatment phase will consist of 3 treatment periods separated by a 5-day safety review period before the next ascending dose of study drug is administered to the next group. Participants in each group will be confined to the study center for a total of 5 days, the total duration of each subject's participation will be up to 33 days, including the screening phase. The total duration of the study (completion of all 3 treatment cohorts) will be up-to-approximately 2 months.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- body mass index between 18 and 30 kg/m², inclusive

- body weight not less than 50 kg

- have a normal electroencephalogram under basic and stimulated conditions

- have a 12-lead ECG that is consistent with normal cardiac conduction and function

- have not used any tobacco products (eg, cigarettes, cigars, chewing tobacco, gum, or

patch) for at least 6 months before first study drug administration Exclusion Criteria:

- any personal or family history of epileptic seizures or convulsions

- have suffered from head trauma with loss of consciousness -have suffered from central

nervous system infection

- have suffered from loss of consciousness of unknown origin

- drowning or sudden infant death syndrome in a first degree relative

Overland Park, Kansas, United States

Starting date: August 2013
Last updated: December 15, 2014