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A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers

Primary Purpose

Erectile Dysfunction

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tadalafil 10 MG
Sponsored by
Seattle Gummy Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • male 19-65 years of age;
  • Available to participate for the planned duration of the study;
  • Able and willing to complete the informed consent process;
  • Agree to have blood samples collected and stored for the study;
  • Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the course of the study;
  • Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to the study;
  • Have not taken nitrates, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors and CYP3A4 inducers for a specified duration of time prior to the study;
  • Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of the study.

Exclusion Criteria:

  • A condition in which repeated blood draws poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access;
  • A condition that requires active medical intervention or monitoring to avert serious danger to the subject's health or well-being;
  • subjects with dentures, partial dentures or braces, subjects with swallowing disorders and subjects who abuse drugs, alcohol or tobacco;
  • Currently taking nitrates or nitro compounds, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors, CYP3A4 inducers;
  • Currently taking any medicines known to conflict with tadalafil;
  • History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study;
  • History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor;
  • History of diabetes;
  • History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study;
  • Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Treatment A: Test

    Treatment B: Reference

    Treatment C: Test

    Treatment D: Test

    Treatment E: Test

    Arm Description

    Single oral dose of tadalafil gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fasted conditions

    Single oral dose of tadalafil oral tablets 10 mg, administered with approximately 240 mL of room temperature water, under fasted conditions

    Single oral dose of tadalafil gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fed conditions

    Single oral dose of tadalafil gummy 10 mg, chewed, administered with no water, under fasted conditions

    Single oral dose of tadalafil gummy 10 mg, swallowed whole, administered with approximately 240 mL of room temperature water, under fasted conditions

    Outcomes

    Primary Outcome Measures

    maximum plasma cetirizine concentration (Cmax)
    PK blood samples to measure plasma concentrations of tadalafil will be collected by direct venipuncture or by use of an indwelling cannula. Blood will be collected into tubes containing K2EDTA for determination of plasma tadalafil concentration at time 0 (within 60 minutes pre-dose), 10, 20 minute post-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post-dose. Plasma tadalafil concentrations will be listed at each time point by subject and summarized by treatment at each time point using descriptive statistics (n, mean, standard deviation (SD), Coefficient of variation (CV%), median, minimum and maximum values). Pharmacokinetic calculations will be performed based on actual time of blood sample collection, using non-compartmental methods with Phoenix WinNonlin Version 8.1 (Certara USA, Inc., Princeton, New Jersey, USA). Plots of mean concentrations of plasma tadalafil versus time will be generated and Cmax will be generated from the plot.
    area under the plasma drug concentration versus time curve (AUC)
    AUC will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ). AUC will be calculated to the last measurable observation (AUC0-t) and extrapolated to infinity (AUC0 ∞).

    Secondary Outcome Measures

    time to Cmax (Tmax)
    Tmax will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
    elimination half-life (t½)
    t½ will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
    terminal elimination rate constant (Kel).
    Kel will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).

    Full Information

    First Posted
    February 17, 2021
    Last Updated
    February 6, 2023
    Sponsor
    Seattle Gummy Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04762082
    Brief Title
    A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers
    Official Title
    A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    January 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Seattle Gummy Company

    4. Oversight

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

    5. Study Description

    Brief Summary
    This is a randomized, open-label, single-dose, five-period crossover, relative bioavailability study to evaluate tadalafil gummy 10mg and tadalafil oral tablets 10mg in healthy volunteers
    Detailed Description
    This is an open-label, single dose, randomized, five-period, crossover design study to evaluate the relative bioavailability of a single oral dose of tadalafil gummy 10 mg (Test) and tadalafil oral tablets 10 mg (Reference) under fasted conditions in healthy adult male and female subjects, and the impact on the bioavailability of tadalafil gummy sugar free 10 mg when administered with food, when administered with or without water, and when chewed or swallowed whole. Each subject will receive tadalafil gummy (10 mg) or tadalafil tablet and thereby will be his/hers own control.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Model Description
    Eligible subjects will receive a single oral dose of one of five treatments (Treatments A, B, C, D or E) in five separate periods in a randomly assigned sequence, with each treatment separated by an approximate 5-day washout period. In each study period, dosing will occur in the morning after an overnight fast of at least 10 hours. All doses will be administered under fasted conditions except for Treatment C, when tadalafil gummy 10 mg will be administered after consumption of a high-calorie, high-fat breakfast. All doses will be administered with approximately 240 mL of room temperature water except for Treatment D, when tadalafil gummy 10 mg dose will be administered without water. All doses of tadalafil gummy 10 mg will be chewed before swallowing except for Treatment E, when subjects will be instructed to swallow the dose whole.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment A: Test
    Arm Type
    Experimental
    Arm Description
    Single oral dose of tadalafil gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fasted conditions
    Arm Title
    Treatment B: Reference
    Arm Type
    Active Comparator
    Arm Description
    Single oral dose of tadalafil oral tablets 10 mg, administered with approximately 240 mL of room temperature water, under fasted conditions
    Arm Title
    Treatment C: Test
    Arm Type
    Experimental
    Arm Description
    Single oral dose of tadalafil gummy 10 mg, chewed, administered with approximately 240 mL of room temperature water, under fed conditions
    Arm Title
    Treatment D: Test
    Arm Type
    Experimental
    Arm Description
    Single oral dose of tadalafil gummy 10 mg, chewed, administered with no water, under fasted conditions
    Arm Title
    Treatment E: Test
    Arm Type
    Experimental
    Arm Description
    Single oral dose of tadalafil gummy 10 mg, swallowed whole, administered with approximately 240 mL of room temperature water, under fasted conditions
    Intervention Type
    Drug
    Intervention Name(s)
    Tadalafil 10 MG
    Intervention Description
    comparison of tadalafil gummy 10mg and tadalafil oral tablet 10mg
    Primary Outcome Measure Information:
    Title
    maximum plasma cetirizine concentration (Cmax)
    Description
    PK blood samples to measure plasma concentrations of tadalafil will be collected by direct venipuncture or by use of an indwelling cannula. Blood will be collected into tubes containing K2EDTA for determination of plasma tadalafil concentration at time 0 (within 60 minutes pre-dose), 10, 20 minute post-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours post-dose. Plasma tadalafil concentrations will be listed at each time point by subject and summarized by treatment at each time point using descriptive statistics (n, mean, standard deviation (SD), Coefficient of variation (CV%), median, minimum and maximum values). Pharmacokinetic calculations will be performed based on actual time of blood sample collection, using non-compartmental methods with Phoenix WinNonlin Version 8.1 (Certara USA, Inc., Princeton, New Jersey, USA). Plots of mean concentrations of plasma tadalafil versus time will be generated and Cmax will be generated from the plot.
    Time Frame
    96 hours
    Title
    area under the plasma drug concentration versus time curve (AUC)
    Description
    AUC will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ). AUC will be calculated to the last measurable observation (AUC0-t) and extrapolated to infinity (AUC0 ∞).
    Time Frame
    96 hours
    Secondary Outcome Measure Information:
    Title
    time to Cmax (Tmax)
    Description
    Tmax will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
    Time Frame
    96 hours
    Title
    elimination half-life (t½)
    Description
    t½ will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
    Time Frame
    96 hours
    Title
    terminal elimination rate constant (Kel).
    Description
    Kel will be determined using non-compartmental analysis methods (Phoenix WinNonlin software, version 8.1 or higher, Certara USA Inc., Princeton, NJ).
    Time Frame
    96 hours

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: male 19-65 years of age; Available to participate for the planned duration of the study; Able and willing to complete the informed consent process; Agree to have blood samples collected and stored for the study; Agree not to use approved or experimental benign prostatic hyperplasia or erectile dysfunction treatments anytime during the course of the study; Have not taken finasteride or dutasteride therapy, any other lower urinary tract symptom (LUTS) therapy or phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to the study; Have not taken nitrates, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors and CYP3A4 inducers for a specified duration of time prior to the study; Have a prostate specific antigen (PSA) score within acceptable range defined for study or negative biopsy of the prostate for cancer within 12 months of the study. Exclusion Criteria: A condition in which repeated blood draws poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access; A condition that requires active medical intervention or monitoring to avert serious danger to the subject's health or well-being; subjects with dentures, partial dentures or braces, subjects with swallowing disorders and subjects who abuse drugs, alcohol or tobacco; Currently taking nitrates or nitro compounds, alpha blockers, antihypertensives, alcohol, CYP3A4 inhibitors, CYP3A4 inducers; Currently taking any medicines known to conflict with tadalafil; History of urinary retention or lower urinary tract (bladder) stones 6 months before the start of the study; History of bladder outlet obstruction or urethral obstruction due to stricture, valves, sclerosis, or tumor; History of diabetes; History of cardiac conditions including angina requiring certain treatment with nitrates, heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study; Certain neurological conditions associated with bladder problems or injuries to the brain or spinal cord within a specified time before starting the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    President
    Phone
    2062570464
    Email
    clinicaltrial@seattlegummy.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Single Dose Randomized Five-Way Crossover Pharmacokinetics (PK) Study of Tadalafil Semi-Chewable (Gummy) Formulations in Healthy Volunteers

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