A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers

Phase 1CompletedNCT01947920

Janssen Scientific Affairs, LLC30 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Tramadol HCl, 50 mgDRUG

50-mg overencapsulated tablet for oral administration

PlaceboDRUG

Size-matching capsules containing an appropriate inactive excipient

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

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

Changes in clinical laboratory results, vital signs, psycopharmacologic status (Richmond Agitation-Sedation Scale (RASS), and physical examination.

Time frame: Baseline, Days 1 through 4

Secondary Outcomes

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

ECG will detect abnormal changes from baseline in cardiac depolarization/repolarization.

Time frame: Baseline, Day 1, Day 3 and Day 4

Change from baseline in pharmacokinetic parameters of tramadol and M1 metabolite

Determination of concentrations of tramadol and M1 metabolite pharmacokinetic parameters in venous plasma.

Time frame: Baseline, up to 72 hours after the 1st dose

Incidence and type of adverse events

Time frame: Baseline, till the end of study

Data from ClinicalTrials.gov

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