Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015

NCT ID: NCT05728671

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-16
• Study Completion Date: 2023-07-20

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.

Conditions

Bioavailability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

IP2015_PO release form 1

Test formulation 1

Group Type: EXPERIMENTAL

IP2015

Intervention Type: DRUG

Test drug

IP2015_PO release form 2

Test formulation 2

Group Type: EXPERIMENTAL

IP2015

Intervention Type: DRUG

Test drug

IP2015_PO release form 3

Test formulation 3

Group Type: EXPERIMENTAL

IP2015

Intervention Type: DRUG

Test drug

Interventions

IP2015

Test drug

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Initiator Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandy Connell, MD

Role: PRINCIPAL_INVESTIGATOR

MAC UK

Central Contacts

Mikael Thomsen, PhD

Role: CONTACT

mt@initiatorpharma.com

23276134

Claus Olesen, PhD

Role: CONTACT

ceo@initiatorpharma.com

61260035

Other Identifiers

IP2015CS04

Identifier Type: -

Identifier Source: org_study_id