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Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects

NCT02054754 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-05-23

Study results available
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Summary

The purpose of this study is to test the safety and observe the pharmacokinetics (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy male subjects following a single oral dose.

Conditions

  • Safety
  • Tolerability
  • Pharmacokinetics
  • Cancer

Interventions

DRUG

Dexanabinol Dose Level 1

Oral formulation of dexanabinol

DRUG

Dexanabinol Dose Level 2

Oral formulation of dexanabinol

DRUG

Dexanabinol Dose Level 3

Oral formulation of dexanabinol

DRUG

Dexanabinol Dose Level 4

Oral formulation of dexanabinol

DRUG

Dexanabinol Dose Level 5

Oral formulation of dexanabinol

DRUG

Placebo

Sponsors & Collaborators

  • e-Therapeutics PLC

    lead INDUSTRY

Principal Investigators

  • Philip Evans, MD · Quotient Clinical

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02054754 on ClinicalTrials.gov