Healthy Volunteer Study Comparing Tablet and Capsule Formulations

Sponsor

Blade Therapeutics (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04001998

Collaborator

(none)

Enrollment

Location

Arms

4.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibrosis	Drug: BLD-2660	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tablet vs Capsule Formulation Single oral dose of BLD-2660 capsule or tablet formulation	Drug: BLD-2660 Randomized to active product
Experimental: Dose Proportionality Single oral dose of BLD-2660 tablet formulation	Drug: BLD-2660 Randomized to active product

Arm

Intervention/Treatment

Experimental: Tablet vs Capsule Formulation

Single oral dose of BLD-2660 capsule or tablet formulation

Drug: BLD-2660

Randomized to active product

Experimental: Dose Proportionality

Single oral dose of BLD-2660 tablet formulation

Drug: BLD-2660

Randomized to active product

Outcome Measures

Primary Outcome Measures

Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) [Up to 40 days]
Measured by plasma concentration
AUC from time 0 to infinity (AUC0-inf) [Up to 40 days]
Measured by plasma concentration
Maximum observed drug concentration (Cmax) [Up to 40 days]
Measured by plasma concentration
Time of the maximum drug concentration (Tmax) [Up to 40 days]
Measured by plasma concentration
Apparent terminal half-life (t½) [Up to 40 days]
Measured by plasma concentration
Apparent terminal elimination rate constant (Kel) [Up to 40 days]
Measured by plasma concentration

Secondary Outcome Measures

Incidence of adverse events (AEs) [Up to 40 days]
AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scientia Clinical Research	Randwick	New South Wales	Australia	2031

Sponsors and Collaborators

Blade Therapeutics

Investigators

Principal Investigator: Charlotte Lemech, MD, Scientia Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Blade Therapeutics

ClinicalTrials.gov Identifier:

NCT04001998

Other Study ID Numbers:

B-2660-102

First Posted:

Jun 28, 2019

Last Update Posted:

Oct 30, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fibrosis

Study Results

No Results Posted as of Oct 30, 2020