A Study to Assess Single and Multiple Doses of IkT-148009 in Healthy Elderly Participants

Overview

This study investigates the safety and tolerability of drug IkT-148009 in healthy elderly volunteers (55 to 70 years old). It also looks at the movement of IkT-148009 in the body. This first-in-human study is designed in 2 parts. In Part A, healthy participants will take a single, oral dose of IkT-148009 or placebo. Part A participants will be at the study site for approximately 4 days. In Part B, healthy participants will take an oral dose of IkT-148009 once a day for 7 days. Part B participants will be at the study site for approximately 9 days.

Full Title of Study: “A Phase I, Randomized Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Determine the Safety, Tolerability and Pharmacokinetics (PK) of IkT-148009 in Elderly Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 28, 2021

Detailed Description

This is a randomized, Phase 1 study in elderly (55 to 70 years old) subjects, otherwise considered to be healthy with the objective of identifying the maximum tolerated dose (MTD) and the pharmacokinetic (PK) profile of IkT-148009 tablets in two different settings; a single dose and a multiple dose setting. Escalation to the next dose will be undertaken only after safety, tolerability and PK data have been reviewed by the Safety Review Committee (SRC) and agreement reached that it is safe to increase the dose.

The single ascending dose cohorts will consist of up to 7 visits over a period of up to 28 days prior to dosing and 14 days after dosing. Multiple ascending dose cohorts will consist of up to 12 visits over a period of 49 days including 7 days of dosing.

Interventions

  • Drug: IkT-148009
    • Oral administration gelatin capsule
  • Drug: Placebo
    • Oral administration gelatin capsule

Arms, Groups and Cohorts

  • Active Comparator: single ascending Dose (SAD)
    • In Part A, cohorts will consist of eight (8) subjects; six (6) of whom will receive treatment with IkT-148009 and two (2) with matching placebo.
  • Active Comparator: Multiple ascending Dose (MAD)
    • In Part B, cohorts will consist of twelve (12) subjects; nine (9) of whom will receive treatment with IkT-148009 and three (3) with matching placebo.

Clinical Trial Outcome Measures

Primary Measures

  • Safety: incidence of abnormal vital sign measurements
    • Time Frame: Safety assessments performed from Day 1 through Day 14
    • body temperature by mouth, blood pressure, pulse rate, pulse oximetry, respiration rate
  • Safety: incidence of abnormal Clinical Laboratory Data
    • Time Frame: Safety assessments performed from Day 1 through Day 14
    • Clinical chemistry tests will include albumin, alkaline phosphatase, total bilirubin, calcium, cholesterol, creatinine, creatinine clearance, creatinine kinase (CK), gamma-glutamyltransferase (γ-GT), glucose, lactate dehydrogenase (LDH), inorganic phosphorus, lipase, amylase, potassium, magnesium, total protein, aspartate transaminase (AST), alanine transaminase (ALT), sodium, triglycerides, urea and uric acid, bicarbonate and chloride. TSH levels will also be monitored. CBC assessments will include hemoglobin, hematocrit, red blood cell (RBC) count, reticulocyte count, white blood cells (WBC) count with differential, platelet count and PT-INR. PT-INR should be reported in both prothrombin time and international normalized ratio. Men and women will undergo additional laboratory tests for reproductive organ function to include leutenizing hormone (LH), follicle stimulating hormone (FSH), testosterone and inhibin B.
  • Safety: incidence of abnormal electrocardiogram [ECG]
    • Time Frame: Safety assessments performed from Day 1 through Day 14
    • An ECG traces the electrical activity of the heart.
  • Safety: C-SSRS
    • Time Frame: Safety assessments performed from Day 1 through Day 14
    • Columbia Suicide Severity Rating Scale questionaire
  • Tolerability (adverse event reporting)
    • Time Frame: Day 1 through 14 days post last dose
    • Adverse events reported
  • Pharmacokinetic AUC of IkT-148009
    • Time Frame: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
    • Area under the concentration-time curve (AUC0-∞)
  • Pharmacokinetic Cmax of IkT-148009
    • Time Frame: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
    • Maximum plasma concentration (Cmax)
  • Pharmacokinetic AUC to last time point of IkT-148009
    • Time Frame: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
    • Area under the concentration-time curve from time zero to last time point (AUC0-last)
  • Pharmacokinetic Tmax of IkT-148009
    • Time Frame: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
    • Time to reach maximum concentration (Tmax)
  • Pharmacokinetic distribution half-life of IkT-148009
    • Time Frame: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
    • The distributional half-life and terminal half-life (t1/2)
  • Pharmacokinetic trough concentration of IkT-148009
    • Time Frame: Part A: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post dose. Part B: As in Part A plus 120, 144, 168, 192 hours post-dose.
    • Exposure (Ctrough)

Participating in This Clinical Trial

Inclusion Criteria

  • Signed informed consent
  • otherwise healthy and ambulatory
  • Female subjects must be postmenopausal or surgically sterile
  • Male subjects must agree to practice an acceptable method of highly effective birth control from the Screening visit, while on study and for 7 days after receiving the last dose of study drug.
  • Males must be willing to abstain from sperm donation from the screening visit and through 30 days after receiving the last dose of study drug.

Exclusion Criteria

  • Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
  • Clinically significant abnormal physical examination or 12-lead electrocardiogram (ECG)
  • Significant history and/or presence of significant medical conditions
  • Any malignancy in the 5 years prior to screening excluding basal cell carcinoma or basal cell carcinoma of the skin or cervical carcinoma in situ that have been successfully treated

Other protocol-defined inclusion/exclusion criteria may apply.

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Inhibikase Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John E. Laabs, MD, Principal Investigator, Celerion
  • Overall Contact(s)
    • Milton Werner, PhD, (678) 392-3419, mhwerner@inhibikase.com

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