A Phase 1 Study to Assess Pharmacokinetics of Metadoxine (MG01CI) 1400 mg, Administered to Healthy Volunteers

Healthy Adult Subjects Clinical Trial

Official title: A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of Metadoxine (MG01CI) 1400 mg, Administered as Repeated Doses to Healthy Volunteers

Status Completed

Clinical Trial 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.

Clinical Trial 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". ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Adult Subjects

• NCT number: NCT01933997
• Study type: Interventional
• Source: Alcobra Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: August 2013
• Completion date: October 2013