Healthy Volunteer Study Comparing Tablet and Capsule Formulations

NCT ID: NCT04001998

Last Updated: 2020-10-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2021-07-31

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.

Conditions

Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tablet vs Capsule Formulation

Single oral dose of BLD-2660 capsule or tablet formulation

Group Type: EXPERIMENTAL

BLD-2660

Intervention Type: DRUG

Randomized to active product

Dose Proportionality

Single oral dose of BLD-2660 tablet formulation

Group Type: EXPERIMENTAL

BLD-2660

Intervention Type: DRUG

Randomized to active product

Interventions

BLD-2660

Randomized to active product

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Blade Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charlotte Lemech, MD

Role: PRINCIPAL_INVESTIGATOR

Scientia Clinical Research

Locations

Scientia Clinical Research

Randwick, New South Wales, Australia

Countries

Australia

Other Identifiers

B-2660-102

Identifier Type: -

Identifier Source: org_study_id