Healthy Volunteer Study Comparing Tablet and Capsule Formulations

NCT04001998 | Withdrawn Phase 1

• 1 other identifier: B-2660-102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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

• AUC from time 0 to infinity (AUC0-inf)

  Measured by plasma concentration

  Up to 40 days

• Maximum observed drug concentration (Cmax)

  Measured by plasma concentration

  Up to 40 days

• Time of the maximum drug concentration (Tmax)

  Measured by plasma concentration

  Up to 40 days

• Apparent terminal half-life (t½)

  Measured by plasma concentration

  Up to 40 days

• Apparent terminal elimination rate constant (Kel)

  Measured by plasma concentration

  Up to 40 days

Secondary Outcomes (1)

• Incidence of adverse events (AEs)

  Up to 40 days

Study Arms (2)

Tablet vs Capsule Formulation

EXPERIMENTAL

Single oral dose of BLD-2660 capsule or tablet formulation

Drug: BLD-2660

Dose Proportionality

EXPERIMENTAL

Single oral dose of BLD-2660 tablet formulation

Drug: BLD-2660

Interventions

BLD-2660 DRUG

Randomized to active product

Dose Proportionality; Tablet vs Capsule Formulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blade Therapeutics: lead

Study Sites (1)

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlotte Lemech, MD

  Scientia Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: February 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)