Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With N… (NCT05735951) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function
Bulgaria39 participantsStarted 2023-07-24
Plain-language summary
The purpose of this study is to determine whether the pharmacokinetics (PK) of stiripentol and of its relevant metabolites would be altered in subjects with renal impairment compared with normal controls in order to assess the need of dose adjustment in the renal impaired population. This study will include subjects with mild, moderate and severe renal impairment.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Male or female subjects, aged 18 to 80 years inclusive,
✓. Females participating in this study must be of non-childbearing potential or using highly effective contraception for the full duration of the study and for 1 month after the end of treatment,
✓. Negative serum pregnancy test at screening and urinary pregnancy test at Day -1 (if applicable),
✓. A negative antigen test for Coronavirus Disease 19 (COVID 19),
✓. Normal hepatic function (AST \< 3xULN (Upper limit normal), ALT (Alanine aminotransferase); \<1.5 ULN; bilirubin),
✓. Non-smoker subject or smoker of not more than 5 cigarettes a day,
✓. Signing a written informed consent in their native language prior to selection,
✓. Documented renal impairment indicated by reduced RF at least 12 months of screening or longer,
Exclusion criteria
✕. Unsuitable veins for repeated venipuncture,
✕. Positive Hepatitis B surface (HBsAg) antigen or positive Hepatitis C Virus (HCV), or positive results for Human Immunodeficiency Virus (HIV)-1 or 2 tests,
✕. History or presence of drug or alcohol abuse (alcohol consumption \>40 grams/day),
✕. Subject/Patient who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development,
What they're measuring
1
Area under the plasma concentration versus time curve
✕. Subject/Patient who cannot be contacted in case of emergency,
✕. History or presence of allergy or unusual reactions to some drugs or anesthetics or known hypersensitivity to the investigation product or its excipients (including lactose intolerance), test material or related compound,
✕. Who receive a medication known to affect both cyochromes (CYP) CYP1A2, CYP3A4, and CYP2C19, such as rifampin, within 1 month prior to the first dose administration. Concomitant use of medications known to strongly affect either CYP1A2, CYP3A4, or CYP2C19, such as phenytoin, phenobarbital or carbamazepine, should be avoided within 1 month prior to the first dose administration.
✕. Subject/Patient who is in the exclusion period of a previous study,