Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Bioavailability

Intervention / Treatment
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* Drug: IP2015


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IP2015_PO release form 1<br>Test formulation 1 | Drug: IP2015<br>* Test drug<br>|
| Experimental: IP2015_PO release form 2<br>Test formulation 2 | Drug: IP2015<br>* Test drug<br>|
| Experimental: IP2015_PO release form 3<br>Test formulation 3 | Drug: IP2015<br>* Test drug<br>|

What is the study measuring?
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Primary Outcome Measures

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