Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers

NCT03866928 | Completed Phase 1 DMC

• 1 other identifier: STP199
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is a monocentric open label study to assess the PK parameters of stiripentol and its metabolites (if any are detected) after multiple oral doses in 14 healthy male subjects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• Maximum Plasma Concentration [Cmax]

  To determine Cmax of stiripentol and its metabolites (if any are detected) in plasma

  On Days 1 and 15

• Area Under the Curve [AUC]

  To determine AUC of stiripentol and its metabolites (if any are detected) in plasma

  On Days 1 and 15

• Time that a drug is present at the maximum concentration [Tmax]

  To determine Tmax of stiripentol and its metabolites (if any are detected) in plasma

  On Days 1 and 15

• The minimum concentration [Cmin]

  To determine Cmin of stiripentol and its metabolites (if any are detected) in plasma

  From Day 2 to Day 15

• Amount of drug excreted in urine [Ae]

  To determine Ae of stiripentol and its metabolites (if any are detected) in urine

  From Day 2 to Day 15

• Fraction of the dose excreted in urine [fe]

  To determine fe of stiripentol and its metabolites (if any are detected) in urine

  From Day 2 to Day 15

Secondary Outcomes (1)

• Treatment-related adverse events [TRAEs]

  From start of participation of the subject until 4 weeks after the last administration of the study drug

Study Arms (1)

Stiripentol

EXPERIMENTAL

Drug: Stiripentol

Interventions

Stiripentol DRUG

1500 mg of stiripentol b.i.d.

Stiripentol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will be required to satisfy the following criteria:
• Healthy male subject, aged between 18 and 45 years inclusive.
• Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination).
• Body mass index (BMI) between 18 and 30 kg/m² inclusive.
• Normal blood pressure (BP) and heart rate (HR) at the screening visit after 5 min in supine position:
• mmHg ≤ Systolic Blood Pressure (SBP) ≤ 145 mmHg,
• mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg,
• bpm ≤ HR ≤ 90 bpm,
• Or considered not clinically significant (NCS) by the Investigator.
• Normal electrocardiogram (ECG) recording on a 10 min resting 12-lead ECG at the screening visit:
• ≤ interval between P and R waves (PR) \< 210 ms,
• Interval between Q and S waves (QRS) \< 120 ms,
• Fridericia corrected interval between Q and T waves (QTcF) ≤ 450 ms,
• No sign of any trouble of sinusal automatism,
• Or considered NCS by the Investigator.

You may not qualify if:

• Unsuitable veins for repeated venipuncture.
• Any relevant history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, infectious disease or psychiatric disorders,
• Evidence of any clinically significant acute or chronic disease,
• Surgery or blood donation (including in the frame of a clinical trial) within 2 months before administration,
• Presence or relevant history of drug hypersensitivity, asthma or allergic disease diagnosed and treated by a physician,
• Known hypersensitivity to any of the test materials or related compounds,
• Inability to abstain from intensive muscular effort,
• Inability or difficulty swallowing whole capsules
• No possibility of contact in case of emergency,
• Any drug intake (except paracetamol) including over the counter (OTC) medications and herbal products that could affect the outcome of the study, within 2 weeks prior to the first drug administration or less than 5 times the t1/2 of that drug, whichever is longer,
• Who receive carbamazepine, phenytoin or phenobarbital known to affect hepatic metabolism within 1 month prior to the first dose administration,
• Who receive any drug known to interfere with CYP enzymes within 1 month prior to the first dose administration,
• History or presence of drug or alcohol abuse (alcohol consumption \> 4 glasses per day (1 glass is approximately equivalent to: beer \[354 mL\], wine \[118 mL\], or distilled spirits \[29.5 mL\]) per day)),
• Excessive consumption of beverages with xanthine bases (\> 5 cups or glasses / day),
• Current use of nicotine containing products, i.e., more than 5 cigarettes or equivalent/day or the inability to stop using nicotine containing products during confinement in the clinical center,

Sponsors & Collaborators

• Biocodex: lead

Study Sites (1)

ATC

Liège, Belgium

Location

MeSH Terms

Interventions

stiripentol

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: February 12, 2019
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)