A Phase 1 Study to Assess Pharmacokinetics of Metadoxine (MG01CI) 1400 mg, Administered to Healthy Volunteers
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      objective: To assess the safety, tolerability and pharmacokinetics of metadoxine,
      administered as repeated oral doses of MG01CI tablets (2 X 700 mg metadoxine per
      administration), to healthy adult subjects.

      This is a single center, open-label, repeated-dose study in healthy male and female
      volunteers. Subjects will undergo screening within 21 days prior to the first dosing to
      assess their eligibility to participate in the study.

      All subjects will receive 1400 mg metadoxine as two MG01CI oral extended-release tablets,
      administered once daily for five consecutive days.

      Blood samples for metadoxine (which consists of two components: pyrrolidone-5-carboxylate and
      pyridoxine that can be identified in plasma concentration assays) will be drawn at designated
      time points, as described in the pharmacokinetic (PK) evaluation section. The subjects will
      remain confined to the unit for 6 days after first dosing.

      A study termination visit will take place 10-12 days after the last dosing day. The subjects
      will be monitored for safety, and AEs (Adverse events) will be recorded throughout the study.
    

Detailed description: 
      This is a single center, open-label, repeated-dose study in healthy male and female
      volunteers. The overall study design is outlined in Figure 3.

      Sixteen (16) healthy subjects will participate in the study (no less than 7 males and no less
      than 7 females).

      The study will comprise a screening period (up to 21 days before first dosing), a dosing
      period in which the subjects will receive a daily single oral administration of 2 tablets,
      each containing 700 mg metadoxine (total of 1400 mg) for five consecutive days, and an
      EOS/Follow-up visit 10-12 days following the last dosing.

      Subjects will be instructed to arrive at the CRC (clinical research center) clinic in the
      evening before the dosing period (Day 0). Check-in procedures will be performed as outlined
      in the Schedule of Events. The subjects will remain in the CRC for approximately 7 days.

      Drugs will be administered after a 10-hour fast with 240 mL water. Drugs will be administered
      while the subjects are in bed sitting at an angle of at least 45 degrees, and, on Dosing Days
      1 (first dosing) and 5 (last dosing) they will remain so for the next 4 hours.

      There will be a 24-hour interval between each dosing. On Dosing Days 1 (first dosing) and 5
      (last dosing) subjects will continue fasting for the next 4 hours post-dose, at which time a
      meal will be provided. Water will be allowed freely until one hour before, and from one hour
      after each dosing. Standardized meals will be provided according to the schedule Blood for PK
      analysis of metadoxine components (pyrrolidone-5-carboxylate L-pyroglutamic acid and
      pyridoxine) will be sampled serially following dosing as per the schedule in the PK
      Evaluation Subjects will be discharged from the CRC approximately 24 hours after the last
      dose.

      There will be an end of study (EOS)/ follow-up visit to assess safety 10-12 days following
      the last dosing.

      Analysis of the blood samples collected at the clinical facility to determine the plasma
      concentrations of metadoxine will be conducted by Avogadro, "Parc de Genibrat 31470
      Fontenilles France".
    

Intervention name(s): Metadoxine (MG01CI )
Intervention type(s): Drug
Other intervention name(s): MG01CI ,metadoxine
Intervention MeSH terms: Pyridoxine; Metadoxine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; metadoxine