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Healthy Volunteer Study Comparing Tablet and Capsule Formulations

Primary Purpose

Fibrosis

Status

Withdrawn

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

BLD-2660

About this trial

This is an interventional treatment trial for Fibrosis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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.

Sites / Locations

Scientia Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Tablet vs Capsule Formulation

Dose Proportionality

Arm Description

Single oral dose of BLD-2660 capsule or tablet formulation

Single oral dose of BLD-2660 tablet formulation

Outcomes

Primary Outcome Measures

Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)

Measured by plasma concentration

AUC from time 0 to infinity (AUC0-inf)

Measured by plasma concentration

Maximum observed drug concentration (Cmax)

Measured by plasma concentration

Time of the maximum drug concentration (Tmax)

Measured by plasma concentration

Apparent terminal half-life (t½)

Measured by plasma concentration

Apparent terminal elimination rate constant (Kel)

Measured by plasma concentration

Secondary Outcome Measures

Incidence of adverse events (AEs)

AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events

Full Information

NCT ID

NCT04001998

First Posted

June 26, 2019

Last Updated

October 29, 2020

Sponsor

Blade Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT04001998

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Withdrawn

Why Stopped

On hold to determine chosen formulations

Study Start Date

February 2021 (Anticipated)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Blade Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tablet vs Capsule Formulation

Arm Type

Experimental

Arm Description

Single oral dose of BLD-2660 capsule or tablet formulation

Arm Title

Dose Proportionality

Arm Type

Experimental

Arm Description

Single oral dose of BLD-2660 tablet formulation

Intervention Type

Drug

Intervention Name(s)

BLD-2660

Intervention Description

Randomized to active product

Primary Outcome Measure Information:

Title

Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)

Description

Measured by plasma concentration

Time Frame

Up to 40 days

Title

AUC from time 0 to infinity (AUC0-inf)

Description

Measured by plasma concentration

Time Frame

Up to 40 days

Title

Maximum observed drug concentration (Cmax)

Description

Measured by plasma concentration

Time Frame

Up to 40 days

Title

Time of the maximum drug concentration (Tmax)

Description

Measured by plasma concentration

Time Frame

Up to 40 days

Title

Apparent terminal half-life (t½)

Description

Measured by plasma concentration

Time Frame

Up to 40 days

Title

Apparent terminal elimination rate constant (Kel)

Description

Measured by plasma concentration

Time Frame

Up to 40 days

Secondary Outcome Measure Information:

Title

Incidence of adverse events (AEs)

Description

AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events

Time Frame

Up to 40 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charlotte Lemech, MD

Organizational Affiliation

Scientia Clinical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Scientia Clinical Research

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

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Healthy Volunteer Study Comparing Tablet and Capsule Formulations

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