An open-label, randomized, single center, adaptive, parallel group study to investigate the single dose oral pharmacokinetics (PK) properties of olesoxime formulated as an oral suspension and as an oral solution in the fed state - Olesoxime BA study

Hoffmann-La Roche0 个研究点目标入组 90 人开始时间: 待定最近更新: 2024年2月28日

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•1. Healthy male and female subjects, 18 to 64 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, and urinalysis.;2. For women of childbearing potential: agreement to remain abstinent or agreement to use an acceptable birth control method during the treatment period and for at least 90 days after the last dose of olesoxime.;3. A body mass index (BMI) between 18.0 to 30.0 kg/m2, inclusive, with a bodyweight < 100 kg on Day -1.;4. Able to participate and willing to give written informed consent and to comply with the study restrictions.

•1. Pregnant (or intending to become pregnant during the study) or lactating women, or positive urine pregnancy test at screening or day -1 (positive urine pregnancy test to be confirmed by a positive serum test).
•2. History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease (multiple allergies, seasonal allergy is acceptable), metabolic disorder, cancer, or cirrhosis.
•3. In the opinion of the Investigator, any clinically significant major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first dose administration.
•4. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel, and urinalysis) at screening. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility.

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