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

Completed

• Conditions: Neurological muscle degeneration; Spinal muscular atrophy; 10029317

• Registration Number: NL-OMON45676
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The pharmacokinetic properties of 10mg/kg olesoxime as oral suspension and<br /><br>20mg/kg olesoxime as oral solution</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The safety and tolerability of 10mg/kg olesoxime as oral suspension and 20mg/kg<br /><br>olesoxime as oral solution</p><br>