Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015

Bioavailability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05728671
• Other study ID #: IP2015CS04
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 16, 2023
• Est. completion date: July 20, 2023

Study information

• Verified date: December 2022
• Source: Initiator Pharma
• Contact: Mikael Thomsen, PhD
• Phone: 23276134
• Email: mt[@]initiatorpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: July 20, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bioavailability

Intervention

Drug:
• IP2015
Test drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Initiator Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC	Pharmacokinetics	72 hours
Primary	Tmax	Pharmacokinetics	72 hours
Primary	Cmax	Pharmacokinetics	72 hours