Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04350177
Recruitment Status : Not yet recruiting
First Posted : April 16, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Inhibikase Therapeutics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Elderly Drug: IkT-148009 Drug: Placebo Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sentinel dosing will be employed for each cohort, with one subject randomized to receive IkT-148009 and the other placebo on the first day. These two subjects in each cohort will be monitored for 48 hours after dosing before deciding to dose the remainder of the cohort. As such, the other six subjects in the first cohort will be dosed approximately 48 hours later. Each cohort will be monitored for at least 48 hours before deciding whether to sentinel pair in the next (higher dose) cohort, and each cohort will be dosed at approximately weekly intervals in order to allow adequate time for collection and review of safety and PK data.
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : March 31, 2021

Arm Intervention/treatment
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.
Drug: IkT-148009
Oral administration gelatin capsule

Drug: Placebo
Oral administration gelatin capsule

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.
Drug: IkT-148009
Oral administration gelatin capsule

Drug: Placebo
Oral administration gelatin capsule




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. Safety: C-SSRS [ Time Frame: Safety assessments performed from Day 1 through Day 14 ]
    Columbia Suicide Severity Rating Scale questionaire

  5. Tolerability (adverse event reporting) [ Time Frame: Day 1 through 14 days post last dose ]
    Adverse events reported

  6. 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-∞)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)


Other Outcome Measures:
  1. Exploratory Biomarker Screen of protein factors [ Time Frame: Part B only, up to 1 year ]
    Biomarker screen in CNS-derived exosomes

  2. Exploratory Biomarker Screen of drug concentration [ Time Frame: Part B only, up to 1 year ]
    IkT-148009 drug concentrations in the CSF in the MAD portion of this study only.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


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): NCT04350177


Contacts
Layout table for location contacts
Contact: Milton Werner, PhD (678) 392-3419 mhwerner@inhibikase.com

Locations
Layout table for location information
United States, Arizona
Celerion, Inc.
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Inhibikase Therapeutics, Inc.
Investigators
Layout table for investigator information
Principal Investigator: John E. Laabs, MD Celerion
Layout table for additonal information
Responsible Party: Inhibikase Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04350177    
Other Study ID Numbers: IkT-148009-101
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No