Clinical trial NCT04001998: Healthy Volunteer Study Comparing Tablet and Capsule Formulations
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Fibrosis
Lead sponsor: Blade Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
timeFrame: Up to 40 days
measure: AUC from time 0 to infinity (AUC0-inf)
timeFrame: Up to 40 days
measure: Maximum observed drug concentration (Cmax)
timeFrame: Up to 40 days
measure: Time of the maximum drug concentration (Tmax)
timeFrame: Up to 40 days
measure: Apparent terminal half-life (t½)
timeFrame: Up to 40 days
measure: Apparent terminal elimination rate constant (Kel)
timeFrame: Up to 40 days
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 40 days
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Scientia Clinical Research
state: New South Wales
Study officials:
affiliation: Scientia Clinical Research
name: Charlotte Lemech, MD
role: PRINCIPAL_INVESTIGATOR
References: