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Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations

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ClinicalTrials.gov Identifier: NCT04814472
Recruitment Status : Active, not recruiting
First Posted : March 24, 2021
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Blade Therapeutics

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

Condition or disease Intervention/treatment Phase
Relative Bioavailability Drug: BLD-0409 Phase 1

Detailed Description:

The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of two oral formulations of BLD-0409, tablet and solution, in healthy volunteers (HV).

The study consists of two parts:

Part 1: A randomized, open-label, 3-period, 6-sequence, complete crossover study with at least 3-day washout between treatment periods comparing oral solution formulation to tablet formulation.

Part 2: A randomized, open-label, 4-period, 4-sequence, complete crossover study with at least 3-day washout between treatment periods evaluating single ascending doses of tablet formulation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution Formulations of BLD-0409 in Healthy Volunteers
Actual Study Start Date : May 16, 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
Experimental: Oral Solution vs. Tablet Formulation

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
Randomized to active product.

Experimental: Tablet Formulation Dose Proportionality

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
Randomized to active product.




Primary Outcome Measures :
  1. Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) [ Time Frame: Up to 16 days ]
    Measured by plasma concentration

  2. Maximum observed drug concentration (Cmax) [ Time Frame: Up to 16 days ]
    Measured by plasma concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

Age and Gender

  1. Male and female participants 18-55 years of age (inclusive) at the time of signing the PICF.

    Diagnosis and disease characteristics

  2. 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.
  3. Participants must have clinical laboratory values within normal ranges or < 1.2 times upper limit of normal (ULN) as specified by the testing laboratory.
  4. Body mass index (BMI) 18 to ≤ 32 kg/m2.

    Reproductive Considerations

  5. Use of acceptable contraception.
  6. 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

  7. 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.

Exclusion Criteria:

Participants meeting ANY of the following exclusion criteria are NOT eligible to be randomized into the study:

Medical Conditions

  1. Recent (less than 6 weeks) wound, or presence of an ongoing non-healing skin wound.
  2. 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.
  3. 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.
  4. Serious local or systemic infection within 1 month of Screening requiring antibiotic treatment or history of recurrent infections.
  5. Surgery within the past 3 months prior to the first study drug administration determined by the Investigator to be clinically relevant.

    Diagnostic Assessments

  6. Positive for human immunodeficiency virus (HIV) antibody or antigen.
  7. Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
  8. 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).
  9. Heart rate < 40 beats per minute (bpm) or > 100 bpm at Screening.
  10. 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.
  11. Females with heavy menstruating cycles and borderline-low iron studies.

    Prior Therapy

  12. 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.
  13. Any estrogen-containing products, e.g., contraceptives, patch, cream, implants within 14 days prior to the first study drug administration.

    Prior/Concurrent Clinical Study Experience

  14. Administration of investigational product in another study within 30 days prior to the first study drug administration, or five half-lives, whichever is longer.

    Other Exclusions

  15. Significant weight loss or gain between Screening and first study drug administration.
  16. Blood donation or significant blood loss within 60 days prior to the first study drug administration.
  17. Plasma donation within 7 days prior to the first study drug administration.
  18. Females who are pregnant or breastfeeding.
  19. Diets that could alter metabolism (i.e., high protein, Slim Fast®, Nutrisystem®, etc.) within 7 days prior first study drug administration.
  20. History or presence of alcohol or drug abuse (including recreational marijuana use) within the 1 year prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period.
  21. Positive urine drug screen/alcohol breath test at Day -1 (admission).
  22. Intake of alcohol or caffeine-containing products from 48 hours before first study drug administration through the EOS visit.
  23. Active smokers and users of nicotine-containing products.
  24. Failure to satisfy the Investigator of fitness to participate for any other reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04814472


Locations
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Australia, New South Wales
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031
Sponsors and Collaborators
Blade Therapeutics
Investigators
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Principal Investigator: Christopher Argent, MD Scientia
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Responsible Party: Blade Therapeutics
ClinicalTrials.gov Identifier: NCT04814472    
Other Study ID Numbers: B-0409-102
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No