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

NCT01121380 | Terminated Phase 1 DMC

• 1 other identifier: BL-1021.01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Healthy; Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Part 1 and 2

Secondary Outcomes (4)

• Mean change from baseline in vital signs

  Part 1 and 2

• Mean change from baseline in laboratory parameters

  Part 1 and 2

• Cmax, Tmax, AUCT, AUCI, kel, T½

  Part 1 and 2

• Dose linearity of PK parameters

  part 1 and 2

Study Arms (8)

Cohort A - 10 mg

EXPERIMENTAL

Drug: BL-1021; Drug: 1021

Cohort B - 20 mg

EXPERIMENTAL

Drug: BL-1021; Drug: 1021

Cohort C - 40 mg

EXPERIMENTAL

Drug: BL-1021; Drug: 1021

Cohort D - 80 mg

EXPERIMENTAL

Drug: BL-1021; Drug: 1021

Cohort E - X mg

EXPERIMENTAL

Part 2, multiple dose. X shall be determined using the results of part 1.

Drug: BL-1021; Drug: 1021

Cohort F - 2X mg

EXPERIMENTAL

Part 2, multiple dose. X shall be determined using the results of part 1.

Drug: BL-1021; Drug: 1021

Cohort G - 4X mg

EXPERIMENTAL

Part 2, multiple dose. X shall be determined using the results of part 1.

Drug: BL-1021; Drug: 1021

Placebo

PLACEBO COMPARATOR

In each cohort there is a placebo arm

Drug: 1021

Interventions

BL-1021 DRUG

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.

Cohort A - 10 mg; Cohort B - 20 mg; Cohort C - 40 mg; Cohort D - 80 mg; Cohort E - X mg; Cohort F - 2X mg; Cohort G - 4X mg

1021 DRUG

1021

Cohort A - 10 mg; Cohort B - 20 mg; Cohort C - 40 mg; Cohort D - 80 mg; Cohort E - X mg; Cohort F - 2X mg; Cohort G - 4X mg; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to provide written informed consent
• Healthy male between 18 and 45 years of age, inclusive
• BMI of 18-30, inclusive
• Negative urinary drugs of abuse screen within 21 days of start of study
• No significant abnormal blood hematology and biochemistry tests according to the opinion of the principal investigator
• Only subjects with a known (pre-study) CYP2D6 genotype will be enrolled.
• No concomitant medications (prescription, OTC, vitamins, dietary supplements) within 7 days prior to administration of study medication
• Non-smoking (by declaration) for a period of at least 6 months prior to enrolment
• Ability to adhere to the visit schedule and protocol requirements and be available to complete the study
• No significant abnormalities in physical examination

You may not qualify if:

• Evidence or history of significant concomitant disease (including mental, CNS-related, renal, hepatic, cardiovascular, pulmonary disease, or other)
• Prior or current history of cancer, except for cured basal cell carcinoma of the skin
• History of significant abnormalities in ECG, including QT prolongation
• History of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm (especially melanoma), or any other clinically significant medical disorder, which in the Investigator's judgment contraindicate administration of the study medications
• Use of another investigational medication/treatment in the past 30 days
• History of drug or alcohol abuse
• Significant abnormalities in screening physical examination
• Significant abnormalities in clinical laboratory parameters (hematology, biochemistry, serology, urinalysis)
• History of gastrointestinal disorder likely to influence drug absorption
• Consumption of Serotonin-Norepinephrine Reuptake Inhibitors (SNRI's), selective serotonin reuptake inhibitors (SSRI's), tricyclic/tetracyclic antidepressants within 90 days prior to Day 0
• Consumption of drugs that may potentially inhibit or induce liver cytochrome P450 activity within 3 weeks prior to Day 0
• Subjects who are either extensive-extensive metabolizers (i.e. carriers of multiple CYP2D6 gene copies) or poor metabolizers of CYP 2D6 will be excluded.
• Any acute medical situation (e.g. acute infection) within 48 hours of Day 0, which is considered of significance by the Principal Investigator
• Unusual diet
• Sero-positive HIV, HBSAg or HCV

Sponsors & Collaborators

• BioLineRx, Ltd.: lead

Study Sites (1)

Hadassah Clinical Research Center (HCRC)

Jerusalem, 91120, Israel

Location

Study Officials

• Yotam Nisemblat

  BioLineRx, Ltd.

  STUDY DIRECTOR

• Yoseph Caraco, Prof, MD

  Hadassah Clinical Research Center (HCRC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

IL (1)