A study to determine the absolute oral bioavailability of N-Acetyl-D-Mannosamine Monohydrate (ManNAc) in healthy adult males.
- Conditions
- GNE MyopathyMusculoskeletal - Other muscular and skeletal disordersHuman Genetics and Inherited Disorders - Other human genetics and inherited disorders
- Registration Number
- ACTRN12622000394741
- Lead Sponsor
- niversity of South Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 6
1. Male and aged 18-59 years, inclusive.
2. Body mass index (BMI) is between 18.0 – 30.0 kg/m2 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.
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, 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 treatment administration in Period 1 (i.e. prior to the first dose of the study).
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 treatment administration in Period 1.
5. Unable or unwilling to refrain from the use of medications, including complementary therapies and supplements, within 5 half-lives of study treatment administration.
6. Major surgery within 4 weeks prior to the screening evaluation, or planned surgery prior to completion of all study procedures in Period 2.
7. Donation of blood or blood products of 470 mL or greater within 12 weeks prior to treatment administration in Period 1, and/or unable or unwilling to refrain from donation from the screening evaluation until completion of all study procedures in Period 2.
8. History or current evidence of alcohol abuse and/or unable or unwilling to refrain from alcohol consumption for 24 h prior to treatment administration 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 in Period 2.
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 treatment administration until completion of all study procedures in each study period.
11. Unable or unwilling to refrain from the use of tobacco products for 24 h prior to treatment administration until completion of all study procedures in each study period.
12. Unable or unwilling to refrain from food intake from 10 h prior until 4 h after treatment administration in each study period.
13. Unable or unwilling to refrain from fluid intake, aside from that given as part of study procedures, from 1 h prior until 2 h after treatment administration in each study period.
14. Unable or unwilling to remain seated in an upright position from immediately prior until 4 h after treatment administration in each study period.
15. Unable or unwilling to be confined to the UniSA Clinical Trial Facility for approximately 12 hours on the specified study days and/or attend the other study visits.
16. Dietary requirements that prevent consumption of the standardised study meals.
17. Poor compliers or those who are unlikely to attend specified study days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method