Healthy Volunteer Study Comparing Tablet and Capsule Formulations

Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04001998
• Other study ID #: B-2660-102
• Status: Withdrawn
• Phase: Phase 1
• Start date: February 2021
• Est. completion date: July 2021

Study information

• Verified date: September 2020
• Source: Blade Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis

Intervention

Drug:
• BLD-2660
Randomized to active product

Locations

Country	Name	City	State
Australia	Scientia Clinical Research	Randwick	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Blade Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)	Measured by plasma concentration	Up to 40 days
Primary	AUC from time 0 to infinity (AUC0-inf)	Measured by plasma concentration	Up to 40 days
Primary	Maximum observed drug concentration (Cmax)	Measured by plasma concentration	Up to 40 days
Primary	Time of the maximum drug concentration (Tmax)	Measured by plasma concentration	Up to 40 days
Primary	Apparent terminal half-life (t½)	Measured by plasma concentration	Up to 40 days
Primary	Apparent terminal elimination rate constant (Kel)	Measured by plasma concentration	Up to 40 days
Secondary	Incidence of adverse events (AEs)	AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events	Up to 40 days