NCT02778386

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 1 Last updated 21 September 2016

What this trial tests

Phase 1 trial testing N-Methanocarbathymidine in Toxicity in 28 participants. Status unknown.

Timeline

1 April 2016

Primary endpoint
1 December 2016

1 December 2016

Quick facts

Lead sponsor	N&N Pharmaceuticals Inc.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	28
Start date	1 April 2016
Primary completion	1 December 2016
Estimated completion	1 December 2016
Sites	1 location across United States

Drugs / interventions tested

• N-Methanocarbathymidine — full drug profile →
• Placebo Capsule

Conditions studied

• Toxicity — all drugs for Toxicity →

Sponsor

N&N Pharmaceuticals Inc. — full company profile →

Who can join

Adults 18 to 45, any sex, with Toxicity. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The Safety and Tolerability of N-MCT Evaluated By The Sequential Review of Reported Adverse Events (AEs) and Changes from Baseline in Findings on Physical Examination, Vital Sign Measurements, and Safety Laboratory Tests
  Time frame: Day 1- Day 7
  The type, incidence, severity and relatedness to study drug of adverse events (AEs), and of abnormal findings on physical examination, vital sign measurements, and of safety laboratory tests (hematology, biochemistry, urinalysis) throughout the study period.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antiviral Therapies for Herpesviruses: Current Agents and New Directions.
   Poole CL, James SH. · · 2018 · cited 112× · PMID 30104016 · DOI 10.1016/j.clinthera.2018.07.006
2. Expanding the repertoire of methanocarba nucleosides from purinergic signaling to diverse targets.
   Jacobson KA, Salmaso V, Suresh RR, Tosh DK. · · 2021 · cited 10× · PMID 34825182 · DOI 10.1039/d1md00167a
3. Large Subunit of the Human Herpes Simplex Virus Terminase as a Promising Target in Design of Anti-Herpesvirus Agents.
   Krasnov VP, Andronova VL, Belyavsky AV, Borisevich SS, et al · · 2023 · cited 5× · PMID 37959793 · DOI 10.3390/molecules28217375