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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04001998




Registration number
NCT04001998
Ethics application status
Date submitted
26/06/2019
Date registered
28/06/2019

Titles & IDs
Public title
Healthy Volunteer Study Comparing Tablet and Capsule Formulations
Scientific 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
Secondary ID [1] 0 0
B-2660-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibrosis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BLD-2660

Experimental: Tablet vs Capsule Formulation - Single oral dose of BLD-2660 capsule or tablet formulation

Experimental: Dose Proportionality - Single oral dose of BLD-2660 tablet formulation


Treatment: Drugs: BLD-2660
Randomized to active product
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
Timepoint [1] 0 0
Up to 40 days
Primary outcome [2] 0 0
AUC from time 0 to infinity (AUC0-inf)
Timepoint [2] 0 0
Up to 40 days
Primary outcome [3] 0 0
Maximum observed drug concentration (Cmax)
Timepoint [3] 0 0
Up to 40 days
Primary outcome [4] 0 0
Time of the maximum drug concentration (Tmax)
Timepoint [4] 0 0
Up to 40 days
Primary outcome [5] 0 0
Apparent terminal half-life (t½)
Timepoint [5] 0 0
Up to 40 days
Primary outcome [6] 0 0
Apparent terminal elimination rate constant (Kel)
Timepoint [6] 0 0
Up to 40 days
Secondary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
Up to 40 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2021
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Blade Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Charlotte Lemech, MD
Address 0 0
Scientia Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04001998