Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations

NCT04814472 | Completed Phase 1

• 1 other identifier: B-0409-102
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution Formulations of BLD-0409 in Healthy Volunteers

Conditions

Relative Bioavailability

Outcome Measures

Primary Outcomes (2)

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

  Measured by plasma concentration

  Up to 16 days

• Maximum observed drug concentration (Cmax)

  Measured by plasma concentration

  Up to 16 days

Study Arms (2)

Oral Solution vs. Tablet Formulation

EXPERIMENTAL

There will be 3 treatments, each single dose administered based on the treatment sequence with at least a 3 day washout between treatments: Treatment A: 750 mg BLD-0409 oral solution formulation (solution) under fasting conditions. Treatment B: 750 mg BLD-0409 tablet formulation (3 x 250 mg tablets) under fasting conditions. Treatment C: 750 mg BLD-0409 tablet formulation (3 x 250 mg tablets) under fed conditions.

Drug: BLD-0409

Tablet Formulation Dose Proportionality

EXPERIMENTAL

There will be 4 treatments, each single dose administered under fed conditions (standard meal) based on the treatment sequence with at least a 3 day washout between treatments: Treatment A: 250 mg BLD-0409 tablet formulation (1 x 250 mg tablet). Treatment B: 500 mg BLD-0409 tablet formulation (2 x 250 mg tablet). Treatment C: 750 mg BLD-0409 tablet formulation (3 x 250 mg tablet). Treatment D: 1000 mg BLD-0409 tablet formulation (4 x 250 mg tablet).

Drug: BLD-0409

Interventions

BLD-0409 DRUG

Randomized to active product.

Oral Solution vs. Tablet Formulation; Tablet Formulation Dose Proportionality

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Age and Gender
• Male and female participants 18-55 years of age (inclusive) at the time of signing the PICF.
• Diagnosis and disease characteristics
• Participants must be in good general health, in the opinion of the Investigator, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening, and/or before administration of the initial dose of study drug.
• Participants must have clinical laboratory values within normal ranges or \< 1.2 times upper limit of normal (ULN) as specified by the testing laboratory.
• Body mass index (BMI) 18 to ≤ 32 kg/m2.
• Reproductive Considerations
• Use of acceptable contraception.
• Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. Females not of childbearing potential must be surgically infertile or post-menopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle-stimulating hormone (FSH) level \> 40 mIU/mL at Screening.
• Informed Consent
• Participants must provide signed informed consent prior to study entry and have the ability and willingness to attend and comply with the necessary visits at the study site.

You may not qualify if:

• Medical Conditions
• Recent (less than 6 weeks) 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 participant will complete the study per protocol.
• Active malignancy and/or history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low grade cervical intraepithelial neoplasia.
• Serious local or systemic infection within 1 month of Screening requiring antibiotic treatment or history of recurrent infections.
• Surgery within the past 3 months prior to the first study drug administration determined by the Investigator to be clinically relevant.
• Diagnostic Assessments
• Positive for human immunodeficiency virus (HIV) antibody or antigen.
• Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
• Systolic blood pressure (BP) \> 150 mmHg or \< 90 mmHg or diastolic BP \> 90 mmHg or \< 50 mmHg at Screening with one repeat allowed per the Investigator's discretion at Screening and Day -1 (Period 1).
• Heart rate \< 40 beats per minute (bpm) or \> 100 bpm at Screening.
• Prolonged QT interval corrected by Fridericia's formula (QTcF) (\> 450 ms for males and \> 470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting ECG, as judged by the Investigator.
• Females with heavy menstruating cycles and borderline-low iron studies.
• Prior Therapy
• All prescription and over the counter medications (including herbal medications), except for non-estrogen contraceptives, are prohibited within 7 days prior to the first study drug administration and throughout the entire duration of the study.

Sponsors & Collaborators

• Blade Therapeutics: lead

Study Sites (1)

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

Location

Study Officials

• Christopher Argent, MD

  Scientia

  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: March 22, 2021
• First Posted: March 24, 2021
• Study Start: May 16, 2021
• Primary Completion: August 17, 2021
• Study Completion: November 3, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)