Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015

An Open-Label, Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015 in Healthy Male Subjects

The study's primary objective is to determine the bioavailability of two solid formulations of IP2015 compared to a liquid formulation of IP2015 in healthy male subjects

Study Overview

• Status: Not yet recruiting
• Conditions: Bioavailability
• Intervention / Treatment: Drug: IP2015

Detailed Description

It is planned to include 12 subjects. Each subject will take part in three treatment periods, in which they will receive a single dose of IP2015 liquid and then to different IP2015 solid formulations, respectively, in each treatment period. Overall, each subject will receive each treatment once only.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive.
• Subject is ≥50 kg.
• Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, clinical laboratory evaluations.

Exclusion Criteria:

• Any significant CNS, cardiac, pulmonary, metabolic, renal, hepatic (including Gilbert's syndrome), gastrointestinal (GI) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion (ADME) of drugs, or with the completion of treatment according to this Protocol.
• Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, GI, hepatic or renal disorder).
• Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs or physical findings at Screening. In case of uncertain or questionable results, tests performed during Screening may be repeated to confirm eligibility or judged to be clinically irrelevant for healthy subjects.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IP2015_PO release form 1; Test formulation 1	Drug: IP2015; Test drug
Experimental: IP2015_PO release form 2; Test formulation 2	Drug: IP2015; Test drug
Experimental: IP2015_PO release form 3; Test formulation 3	Drug: IP2015; Test drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC	Pharmacokinetics	72 hours
Tmax	Pharmacokinetics	72 hours
Cmax	Pharmacokinetics	72 hours

Collaborators and Investigators

• Sponsor: Initiator Pharma

Study record dates

Study Major Dates

• Study Start (Anticipated): February 16, 2023
• Primary Completion (Anticipated): May 16, 2023
• Study Completion (Anticipated): July 20, 2023

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: February 5, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 5, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IP2015CS04

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