An open-label, randomised, three-arm crossover study to examine the comparative pharmacokinetics of ManNAc administered as an oral solution and as two novel oral tablet formulations in healthy adult males

niversity of South Australia0 sites6 target enrollmentJune 2, 2023

ConditionsGNE Myopathy Hereditary Inclusion Body Myopathy Musculoskeletal - Other muscular and skeletal disorders

Overview

Phase: 未知
Intervention: Not specified
Conditions: GNE Myopathy
Sponsor: niversity of South Australia
Enrollment: 6
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 2, 2023

End Date

September 15, 2023

Last Updated

last year

Study Type

Interventional

Sex

Male

Investigators

Sponsor

niversity of South Australia

Eligibility Criteria

Inclusion Criteria

•1\. Male and aged 18\-59 years, inclusive.
•2\. Body mass index (BMI) is between 18\.0 – 30\.0 kg/m^2 with a body weight between 45\.0 – 120\.0 kg.
•3\. Medically healthy without any clinically significant abnormalities. Health status will be determined by the participant's medical history with specific attention to: (i) drug history, identifying any known drug allergies or drug abuse, (ii) any chronic use of medication, and (iii) a thorough review of body systems (vital signs, electrocardiogram (ECG), physical examination and clinical laboratory tests).
•4\. Adequate venous access on their left or right arm to allow for collection of multiple blood samples.
•5\. Aware of the study procedures and the risks involved, and voluntarily agrees to participate by providing written informed consent.
•6\. Willing and able to understand the study procedures and communicate effectively with study personnel.

Exclusion Criteria

•1\. History or presence of any medical condition that, in the opinion of the Medical Officer, may pose an unacceptable level of risk to participants or study staff, may interfere with the interpretation of safety data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of ManNAc.
•2\. History of hypersensitivity to ManNAc or ingredients within the formulations or, in the judgment of the Medical Officer, has a condition that places the participant at increased risk for adverse effects.
•3\. Ingestion of an investigational medication or a new chemical entity within 30 days or 5 half\-lives (whichever is longer) prior to dosing in Period 1\.
•4\. Treated with ManNAc, sialic acid, intravenous immunoglobulin (IVIg), and/or other supplement containing sialic acid (e.g. St. John’s Wort, sialyllactose) within 120 days prior to dosing in Period 1\.
•5\. Unable or unwilling to refrain from the use of medications, including complementary therapies and supplements, within 5 half\-lives of, or for 24 h prior to dosing (whichever is longer) until completion of all study procedures within each study period.
•6\. Major surgery within 4 weeks prior to the screening evaluation, or planned surgery prior to completion of all study procedures.
•7\. Donation of blood or blood products of 470 mL or greater within 12 weeks prior to dosing in Period 1, and/or unable or unwilling to refrain from donation from the screening evaluation until completion of all study procedures.
•8\. History or current evidence of alcohol abuse and/or unable or unwilling to refrain from alcohol consumption for 24 h prior to dosing until completion of all study procedures in each study period.
•9\. History or current evidence of drug abuse, positive urine drug screen during screening, and/or unable or unwilling to refrain ingestion of drugs of abuse from the screening evaluation until completion of all study procedures.
•10\. Unable or unwilling to refrain from consuming food and/or beverages that contain caffeine or other xanthines (e.g. coffee, tea, cola, energy drinks and chocolate) for 24 h prior to dosing until completion of all study procedures in each study period.