Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015

NCT05728671 | Unknown Phase 1

• 1 other identifier: IP2015CS04
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bioavailability

Outcome Measures

Primary Outcomes (3)

• AUC

  Pharmacokinetics

  72 hours

• Tmax

  Pharmacokinetics

  72 hours

• Cmax

  Pharmacokinetics

  72 hours

Study Arms (3)

IP2015_PO release form 1

EXPERIMENTAL

Test formulation 1

Drug: IP2015

IP2015_PO release form 2

EXPERIMENTAL

Test formulation 2

Drug: IP2015

IP2015_PO release form 3

EXPERIMENTAL

Test formulation 3

Drug: IP2015

Interventions

IP2015 DRUG

Test drug

IP2015_PO release form 1; IP2015_PO release form 2; IP2015_PO release form 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Initiator Pharma: lead

Study Officials

• Sandy Connell, MD

  MAC UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael Thomsen, PhD

CONTACT

23276134; mt@initiatorpharma.com

Claus Olesen, PhD

CONTACT

61260035; ceo@initiatorpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: February 15, 2023
• Study Start: February 16, 2023
• Primary Completion: May 16, 2023
• Study Completion: July 20, 2023
• Last Updated: February 15, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share