Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015

Phase 1

Not yet recruiting

• Conditions: Bioavailability
• Interventions: Drug: IP2015

• Registration Number: NCT05728671
• Lead Sponsor: Initiator Pharma

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 Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2023-02-05
• Last Update Submitted: 2023-02-05
• Study First Posted: 2023-02-15
• Last Update Posted: 2023-02-15
• Study Start: 2023-02-16
• Primary Completion: 2023-05-16
• Study Completion: 2023-07-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IP2015_PO release form 1	IP2015	Test formulation 1
IP2015_PO release form 2	IP2015	Test formulation 2
IP2015_PO release form 3	IP2015	Test formulation 3

Primary Outcome Measures

Name	Time	Method
AUC	72 hours	Pharmacokinetics
Cmax	72 hours	Pharmacokinetics
Tmax	72 hours	Pharmacokinetics