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Healthy Volunteer Study Comparing Tablet and Capsule Formulations

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ClinicalTrials.gov Identifier: NCT04001998
Recruitment Status : Withdrawn (On hold to determine chosen formulations)
First Posted : June 28, 2019
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Blade Therapeutics

Brief Summary:
Single center, randomized, open label, two-part crossover study designed to evaluate the PK, food effect, dose proportionality, safety, and tolerability of BLD-2660 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Fibrosis Drug: BLD-2660 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-Part, Open Label, Complete Crossover Study to Compare the Tablet and Capsule Formulations of BLD-2660, Including a Food Effect Assessment of the Tablet Formulation, and to Assess Dose Proportionality Following Single Oral Doses of BLD-2660 in Tablet Formulation
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Tablet vs Capsule Formulation
Single oral dose of BLD-2660 capsule or tablet formulation
Drug: BLD-2660
Randomized to active product

Experimental: Dose Proportionality
Single oral dose of BLD-2660 tablet formulation
Drug: BLD-2660
Randomized to active product




Primary Outcome Measures :
  1. Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) [ Time Frame: Up to 40 days ]
    Measured by plasma concentration

  2. AUC from time 0 to infinity (AUC0-inf) [ Time Frame: Up to 40 days ]
    Measured by plasma concentration

  3. Maximum observed drug concentration (Cmax) [ Time Frame: Up to 40 days ]
    Measured by plasma concentration

  4. Time of the maximum drug concentration (Tmax) [ Time Frame: Up to 40 days ]
    Measured by plasma concentration

  5. Apparent terminal half-life (t½) [ Time Frame: Up to 40 days ]
    Measured by plasma concentration

  6. Apparent terminal elimination rate constant (Kel) [ Time Frame: Up to 40 days ]
    Measured by plasma concentration


Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Up to 40 days ]
    AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to provide written informed consent
  • Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing
  • Normal BMI (18 to ≤ 35 kg/m2)
  • Have a negative urine drug screen/alcohol breath test on admission to clinic
  • Agree to use highly effective, double barrier contraception (both male and female partners) during the study and for 90 days following completion of dosing
  • Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test on Day -1
  • Be in general good health
  • Clinical laboratory values within normal range

Exclusion Criteria:

  • Recent wound, or presence of an ongoing non-healing skin wound
  • Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will complete the study per protocol
  • History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period
  • Blood donation or significant blood loss within 30 days prior to the first study drug administration
  • Plasma donation within 7 days prior to the first study drug administration
  • Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration, or five half-lives, whichever is longer
  • Females who are pregnant or lactating
  • Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant
  • Failure to satisfy the PI of fitness to participate for any other reason
  • Active infection or history of recurrent infections
  • Active malignancy and history of malignancy in the past 2 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia
  • Antibiotic treatment within 3 months
  • Chronic medical condition
  • Any acute illness within 30 days prior

Other protocol defined inclusion/exclusion criteria could apply.


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): NCT04001998


Locations
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Australia, New South Wales
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Sponsors and Collaborators
Blade Therapeutics
Investigators
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Principal Investigator: Charlotte Lemech, MD Scientia Clinical Research
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Responsible Party: Blade Therapeutics
ClinicalTrials.gov Identifier: NCT04001998    
Other Study ID Numbers: B-2660-102
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes