ACTRN12619000101189CompletedPhase 1
A Phase 1, Single Center, Open-Label, Randomized, Two-Period, Two- Arm Crossover Study Of The Bioavailability Of A Single Dose Of N- Acetyl-D-Mannosamine Monohydrate (ManNAc) In A Fasted Condition and A Fed Condition In Healthy Adults
ational Institute of Health - NHGRI Undiagnosed Disease Program0 sites16 target enrollmentStarted: January 23, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 16
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 59 Years (—)
- Sex
- All
Inclusion Criteria
- •1.The subject is a healthy male or female, 18-59 years of age, inclusive
- •2.Body mass index (BMI) between 18 and 30 kg/m2, inclusive; and a body weight in the range of 45 to 100 kg
- •3.Medically healthy without clinically significant (CS) abnormalities at the screening visit or Day -1, including:
- •4.The subject has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent
- •5.Females must be of non-childbearing potential (surgically sterile or post-menopausal for at least 1 year) or be practicing a highly effective contraception method from consent to at least 10 days after the last dose of study medication.
- •6.Males engaging in sexual intercourse with a female partner of childbearing potential must be vasectomized (at least 6 months prior to dosing) or be practicing a highly effective contraception method from consent to at least 10 days after the last dose of study medication.
- •7.Females of childbearing potential have a negative urine pregnancy test during screening and equal or less than 24 hours prior to study dosing, and are not lactating
- •8.Negative test for selected drugs of abuse, alcohol, and cotinine at the Screening visit and on Day -1
- •9.Nonsmoker, defined as not having smoked or used any form of tobacco or nicotine containing products in more than 6 months before screening
- •10.The subject is willing and able to understand the study procedures, to communicate meaningfully with the study personnel, and to comply with the study protocol
- •11.Subjects must be willing to be confined at the clinical research center for the protocol- specified study days
Exclusion Criteria
- •1.History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions or history of any conditions that, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in this trial, may interfere with the interpretation of safety and/or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of the study drugs
- •2.Participation in a clinical trial or receipt of an investigational medication or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of the medication (whichever is longer) prior to the first dose of study medication
- •3.Use of prescription or non-prescription medications, including herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, or use of St. John’s Wort within 120 days prior to the first dose of study medication
- •4.Consumption of grapefruit, grapefruit juice, orange juice, Seville oranges, or red wine within 7 days prior to administration of study medication
- •5.Donation of blood or blood products in excess of 550 mL within 4 weeks prior to administration of study medication
- •6.Subject has hypersensitivity to ManNAc or components thereof or in the judgment of the investigator, has a condition that places the subject at increased risk for adverse effects
- •7.Subject has been treated with ManNAc, sialic acid, intravenous immunoglobulin (IVIG), and/or other supplements containing sialic acid (e.g. St. John’s wort, sialyllactose) less than 120 days prior to administration of study medication
- •8.Unwillingness to use appropriate contraceptive measures if engaging in sexual intercourse with a female partner of childbearing potential.
- •9.Major surgery within 4 weeks of screening
- •10.Uncontrolled intercurrent illness (i.e. active infection)
- •11.Any other medical or psychiatric illness that could, in the Investigator’s opinion, interfere with the completion of the study procedures specified in this protocol
- •12.Wishing to become pregnant during study participation or unwilling to use birth control
- •13.Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg) or Hepatitis C Antibody (HCVAb)
- •14.History of regular alcohol consumption exceeding 7 drinks per week for females and 14 drinks per week for males within 6 months of screening
Investigators
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