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Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.

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ClinicalTrials.gov Identifier: NCT01990885
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the safety of different amounts of BL-7010 in single oral administration and in repeated oral administration to well-controlled celiac patients. Another purpose is to evaluate if BL-7010 is absorbed by the body or not.

Condition or disease Intervention/treatment Phase
Celiac Disease Drug: BL-7010 Drug: Placebo Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A Two-Part, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Systemic Exposure Of Single Escalating Administrations And Repeated Administration Of Bl-7010 In Well-Controlled Celiac Patients
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Two-Part, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Systemic Exposure of Single Escalating Administrations and Repeated Administration of BL-7010 in Well-Controlled Celiac Patients
Study Start Date : December 2013
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cohort A
Each subject will receive a single administration of either BL-7010 (at different amounts) or matching Placebo on 3 treatment occasions in a randomized double-blind fashion
Drug: BL-7010
Other Name: BL7010
Drug: Placebo
Experimental: Cohort B
Each subject will receive a single administration of either BL-7010 (at different amounts) or matching Placebo on 3 treatment occasions in a randomized double-blind fashion
Drug: BL-7010
Other Name: BL7010
Drug: Placebo
Experimental: Cohort C
Each Subject will receive either BL-7010 or Placebo 3 times a day for 14 days(amount to be based on results from Cohorts A and B) in a randomized double-blind fashion
Drug: BL-7010
Other Name: BL7010
Drug: Placebo
Experimental: Cohort D
Each Subject will receive either BL-7010 or Placebo 3 times a day for 14 days(amount to be based on results from previous cohorts) in a randomized double-blind fashion
Drug: BL-7010
Other Name: BL7010
Drug: Placebo
Experimental: Cohort E
Each Subject will receive either BL-7010 or Placebo 3 times a day for 14 days(amount to be based on results from previous cohorts) in a randomized double-blind fashion
Drug: BL-7010
Other Name: BL7010
Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: For Part 1 subjects will be followed for up to 7 weeks from time of first administration. For Part 2 subjects will be followed for up to 4 weeks from time of first administration ]
  2. Significant change from baseline in vital signs and 12-lead ECG parameters [ Time Frame: For Part 1 subjects will be followed for up to 7 weeks from time of first administration. For Part 2 subjects will be followed for up to 4 weeks from time of first administration ]
  3. Significant change from baseline in laboratory safety parameters [ Time Frame: For Part 1 subjects will be followed for up to 7 weeks from time of first administration. For Part 2 subjects will be followed for up to 4 weeks from time of first administration ]

Secondary Outcome Measures :
  1. Plasma levels of BL-7010 [ Time Frame: Over a 24 hour period ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females aged 18-75 years who have signed an informed consent form
  • Body mass index (BMI) between 18.5-29.9, inclusive
  • Documented history of biopsy-proven celiac disease.
  • Adherence to a gluten-free diet for the last 6 months prior to randomization
  • TG2 and EMA antibody (IgA) negative
  • Women of childbearing potential and all men must agree to use an approved form of contraception
  • Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment.

Exclusion Criteria:

  • IgA deficiency.
  • History of IgE-mediated reactions to gluten.
  • Other food sensitivities or allergies.
  • Use of oral steroids, biologics, immunosuppressants or non-steroidal anti-inflammatory drugs 6 months prior to entry (screening).
  • Female subjects who are pregnant or breastfeeding.
  • Clinically significant, concomitant gastrointestinal disease.
  • Have clinically significant current or historical medical problems such as diabetes mellitus, clinically significant cardiac arrhythmias, arteriosclerotic heart disease, renal insufficiency or failure, autoimmune disease, history of malignant melanoma or history of cancer (excluding basal cell carcinoma) within the past 5 years prior to screening.
  • Subjects receiving drugs or oral devices that, in the opinion of the Investigator, possible ineffective treatment with these drugs/oral devices for a duration of two weeks will put the subject at a medical risk
  • Uncontrolled complications of celiac disease.
  • Any other condition that in the opinion of the Investigator will place the subject at risk or prevent protocol compliance.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990885


Locations
Finland
FinnMedi Clinical Trial Center
Tampere, Finland
CRST Clinical Research Services
Turku, Finland
Sponsors and Collaborators
BioLineRx, Ltd.
Investigators
Principal Investigator: Markku Mäki, Professor University of Tampere
More Information

Responsible Party: BioLineRx, Ltd.
ClinicalTrials.gov Identifier: NCT01990885     History of Changes
Other Study ID Numbers: BL-7010.01
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases