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A Study Intended to Evaluate Safety, Tolerability and Pharmacokinetics (PK) Parameters of BL-1021

NCT01121380 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-03-13

No results posted yet for this study

Summary

The purpose of this study is to test the safety, tolerability and pharmacokinetics of BL-1021 in healthy volunteers. Subsequent clinical studies will be designed to test the safety and efficacy of BL-1021 in patients with neuropathic pain based on data obtained from the proposal trial described below.

Conditions

  • Healthy
  • Volunteers

Interventions

DRUG

BL-1021

BL-1021 is an orally available NCE which contains an elongated aliphatic side-chain. Dosage: Part 1 - Single Dose: 1 dose on Day 1, dosage will be 10, 20, 40 \& 80 mg according the cohort Part 2 - Multiple Dosing: up to 7 once-daily administrations. Dosage will be determined according the first part results.

DRUG

1021

1021

Sponsors & Collaborators

  • BioLineRx, Ltd.

    lead INDUSTRY

Principal Investigators

  • Yotam Nisemblat · BioLineRx, Ltd.

  • Yoseph Caraco, Prof, MD · Hadassah Clinical Research Center (HCRC)

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Israel

Study Locations

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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 NCT01121380 on ClinicalTrials.gov