Healthy Volunteer Study Comparing Tablet and Capsule Formulations

Blade Therapeutics

Status and phase: Withdrawn; Phase 1

Conditions: Fibrosis

Treatments: Drug: BLD-2660

Study type: Interventional

Funder types: Industry

Identifiers

NCT04001998

B-2660-102

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Tablet vs Capsule Formulation

Experimental group

Description:

Single oral dose of BLD-2660 capsule or tablet formulation

Treatment:

Drug: BLD-2660

Dose Proportionality

Experimental group

Description:

Single oral dose of BLD-2660 tablet formulation

Treatment:

Drug: BLD-2660