Multiple sclerosis nerve disease
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Signed informed consent prior to any study-mandated procedure; - Males or females, aged 18-70 years; - BMI between: 18-30 kg/m2, minimal weight 50 kg - Ability to communicate well with the investigator in the Dutch language. - Ability to easily visit CHDR in Leiden oncea week - Expected compliance to the protocol with respect to drinking D2O 2 times every day for 70 days
Exclusion criteria
Exclusion criteria: - Clinically significant abnormalities, as judged by the Investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In case of uncertain or questionable results, tests performed during screening may be repeated before the first occasion to confirm eligibility or judged to be clinically irrelevant. - Subject is pregnant or breastfeeding. - Any contraindication for a lumbar puncture. - Recent (within 60 days) or current use of medications. - Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year. - Positive test for drugs of abuse at screening or pre-dose. - Alcohol is prohibited from 24 hours before screening and the first visit. - History or symptoms of any significant disease including (but not limited to) neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder. - Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening. - Donation of blood over 500 mL within 3 months prior to screening. - Unwillingness or inability to comply with the study protocol for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fractional synthesis rate of galactosylceramide (fGalC) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Fractional synthesis rate of sulfatide (fSulft). • Percentage D2O enrichment in body water as determined in urine and plasma. • (Myelin) lipid and proteins markers in plasma samples. • Total concentration of galactosylceramide and sulfatide in the CSF. Safety/tolerability endpoints: • AEs leading to premature discontinuation of D2O. • Treatment-emergent (S)AEs up to 5 half-lives after D2O discontinuation. • Change from baseline to end-of-study in vital signs: blood pressure and heart rate. • Treatment-emergent ECG abnormalities up to 5 half-lives after D2O discontinuation. • Treatment-emergent marked laboratory abnormalities up to 5 pharmacokinetic half-lives after D2O discontinuation | — |
Countries
Netherlands
Outcome results
None listed