NCT02778386

Evaluating the Safety and Plasma Levels of N-Methanocarbathymidine (N-MCT) in Normal Patients

Phase I Trial to Assess the Safety and Pharmacokinetics of a Single Ascending Dose (SAD) of N-Methanocarbathymidine (N-MCT) in Normal Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: N&N Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This Phase I evaluation of N-MCT in normal volunteers requires sequentially increased doses. At each dose level, the safety and pharmacokinetic will be measured. This Phase I trial will have the dose range of N-MCT from 200mg - 1200mg per patient.

Detailed description

This is a Phase 1 trial evaluating the safety and pharmacokinetics of N-MCT administered orally as a single ascending dose. Healthy male and female (non-pregnant, non-lactating) subjects ages 18-45, will be consented and allowed to participate in the study if upon screening they meet the inclusion / exclusion criteria. Subjects will be enrolled into one of four cohort groups sequentially. Each of the six subjects in each group will receive doses sequentially within 48 hours between each dose increase (ie, the second subject in a group will not receive a dose until 48 hours after the first subject received a dose). Cohort 1 (6 subjects, male \& female) will receive 200 mg, Cohort 2 (6 subjects, male \& female) will receive 400 mg, Cohort 3 (8 subjects, males and females, 2 placebo, 6 treated) will receive 800 mg and Cohort 4 (8 subjects, males and females, 2 placebo, 6 treated) will receive 1200 mg of N-MCT. Each cohort will be completed and the safety data evaluated prior to initiating the next cohort. All subjects will have plasma and urine samples evaluated for N-MCT. The PI of the protocol and the IDMC will review safety data (AEs), safety labs, vital signs, and findings through Day 7 for Cohort 1 before enrolling subjects in Cohort 2. Cohort 2 data through Day 7 will be reviewed accordingly by the PI and IDMC before enrolling subjects in Cohort 3. Cohort 3 data through Day 7 will be reviewed by the PI and the IDMC before enrolling subjects in Cohort 4. However, prior to dose escalation to a new cohort as described above, GHUCCTS IRB will review and approve, in expedited review, the IDMC report upon which the decision to escalate the dose to a new cohort is based.

Conditions

• Toxicity

Interventions

Type	Name	Description
DRUG	N-Methanocarbathymidine	Patients will receive 200 mg, 400 mg, 800 mg or 1200 mg of N-Methanocarbathymidine administered orally on day 1 after subject's full screen for each cohort. Each dose will be completely evaluated for safety and pharmacokinetics. The doses of each cohort will be given after complete evaluation of the preceding cohort for any sign of toxicity. In the absence of no observed toxicity, the next cohort will be started in the normal subjects.
OTHER	Placebo Capsule	Two patients in Cohort 3 \& 4 will receive placebo capsules which is mannitol filled into size 0 capsules.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-05-19
• Last updated: 2016-09-22

Locations

1 site across 1 country: United States