A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001

A Randomized, Open-Label, Exploratory, Pharmacokinetic, Sequential Single Ascending Dose Study of IVL3001 Versus Propecia (Finasteride) Tablets in Healthy Adult Participants

A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: Finasteride 1mg Tablet; Drug: IVL3001

Detailed Description

A Randomized, Open-Label, Exploratory, Pharmacokinetic, Sequential Single Ascending dose Study of IVL3001 Versus Propecia (Finasteride) Tablets in Healthy Adult Participants

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia
    • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male, non-smoker or, if a moderate or occasional smoker (< 10 cigarettes per day or nicotine equivalent) must agree to abstain from smoking from 48 h before first IP administration through to completion of the final EOS/ET visit, aged ≥ 18 to 55 years (inclusive at the time of informed consent)
• In good general health, in the opinion of the Investigator, with no significant medical history, and have no clinically significant abnormalities on complete physical examination, 12-lead ECG, heart rate, and BP, both at Screening and before administration of the initial dose of IP
• Body mass index (BMI) between ≥ 18 kg/m2 and ≤ 32 kg/m2 and a minimum weight ≥ 50 kg and ≤ 100 kg at Screening
• Clinical laboratory values within normal limits, with normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate
• Ability and willingness to attend the necessary visits to the CRU and be domiciled overnight
• Willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any protocol-specific study procedures

Exclusion Criteria:

• Prior or ongoing medical conditions, medical history, physical examination findings, or laboratory abnormalities that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant
• Presence or history of any clinically significant blood, kidney, endocrine, lung, gastrointestinal tract, cardiovascular, liver, or neurological condition
• Presence of any underlying physical or psychological (eg, depression) medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol. Mild depression and anxiety that has been resolved at least 6-12 months ago is accepted.
• Presence of any medical condition that may affect oral drug absorption (eg, gastrectomy, gall bladder removal, bariatric surgery, gastric bypass and sleeve, bowel resection)
• Hypersensitivity to finasteride or to any excipient of the IPs
• Age adjusted PSA between 0 2.5 ng/mL for subjects ≤ 50 years of age and between 0-4 ng/mL for subjects > 50 years of age at Screening, unless deemed not clinically significant by the Investigator or delegate
• History or known presence of any prostatic problem (infection, prostate cancer, stricture disease, hypotonic bladder or other neurogenic disorder that might mimic BPH)
• Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), HIV antigen or antibody at Screening
• Positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol [THC], amphetamines, benzodiazepines, opiates and cocaine), or a positive alcohol breath (or urine), or cotinine test
• History of alcohol or substance abuse or dependency, or history of recreational intravenous (IV) drug use over the last 1 year (by self-declaration)
• Regular alcohol consumption defined as > 21 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit, or a 125 mL glass of wine) within 6 months of Screening.
• Use of any IP or investigational medical device within 3 months prior to Screening, or five half-lives of the product (whichever is the longest), or participation in more than 4 investigational drug studies within 1 year prior to Screening
• Use of any drug known to significantly induce or inhibit drug absorption or metabolism within 30 days prior to dosing
• An employee, or relative of an employee, directly involved in the conduct of the study
• Unwilling to refrain from strenuous exercise from 48 hours prior to admission to the CRU at Day -1 and 48 hours prior to each follow-up
• Presence of sexual dysfunction such as decreased libido, erectile dysfunction, or ejaculation disorder
• Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2 at Screening
• Any reason which, in the opinion of the PI, would prevent the subject from participating in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propecia; Propecia Tablet, QD, PO	Drug: Finasteride 1mg Tablet; Propecia Tablet 1mg
Experimental: IVL3001 (A mg); S.C, Single Dose.	Drug: IVL3001; Finasteride long acting injection
Experimental: IVL3001 (B mg); S.C, Single Dose.	Drug: IVL3001; Finasteride long acting injection
Experimental: IVL3001 (C mg); S.C, Single Dose.	Drug: IVL3001; Finasteride long acting injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUClast of IVL3001	Area under the concentration-time curve from time zero to last	Pre-dose, 1008 hours
AUCinf of IVL3001	Area under the concentration-time curve from time zero to infinity	Pre-dose, 1008 hours
AUC0-1008h of IVL3001	Area under the concentration-time curve from time zero to 1008 hours	Pre-dose, 1008 hours
AUClast of Propecia	Area under the concentration-time curve from time zero to last	Pre-dose, 816 hours
AUCinf of Propecia	Area under the concentration-time curve from time zero to infinity	Pre-dose, 816 hours
AUC0-672h of Propecia	Area under the concentration-time curve from time zero to 672hours	Pre-dose, 672 hours

Collaborators and Investigators

• Sponsor: Inventage Lab., Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Actual): February 8, 2022
• Study Completion (Actual): February 8, 2022

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Finasteride
• Other Study ID Numbers: IVL3001-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No