NCT05728671Not yet recruitingPhase 1
An Open-Label, Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015 in Healthy Male Subjects
Initiator Pharma0 sites12 target enrollmentStarted: February 16, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 12
- Primary Endpoint
- AUC
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
IP2015_PO release form 1
Experimental
Test formulation 1
Intervention: IP2015 (Drug)
IP2015_PO release form 2
Experimental
Test formulation 2
Intervention: IP2015 (Drug)
IP2015_PO release form 3
Experimental
Test formulation 3
Intervention: IP2015 (Drug)
Outcomes
Primary Outcomes
AUC
Time Frame: 72 hours
Pharmacokinetics
Cmax
Time Frame: 72 hours
Pharmacokinetics
Tmax
Time Frame: 72 hours
Pharmacokinetics
Secondary Outcomes
No secondary outcomes reported
Investigators
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