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

Status unconfirmed · Phase 1 · Has a placebo group

Conditions studied: Toxicity

In brief

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.

Key facts

Study ID

NCT02778386

Run by

N&N Pharmaceuticals Inc.

People needed

28

Starts

2016-04-01

Expected to finish

2016-12-01

Last updated by the study team

2016-09-22

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must meet all Inclusion Criteria to be included in the study:
• Healthy men and women 18 to 45 years of age, inclusive
• Ability to understand the consent process and study procedures
• Informed consent obtained and signed
• Comprehension of the protocol, as determined by the clinic personnel using a series of questions after explaining the procedures.
• Subjects agree to be available for all study visits.
• General good health, no current medical illness or clinically significant abnormal physical examination findings as determined by study physician investigators
• Negative past or current history of herpes virus infections, or no current use of antiviral medications for the treatment of herpes virus infections
• Negative serum pregnancy test at screening and a negative serum pregnancy test on the day of admission to the inpatient phase for all female subjects of child bearing potential.
• Negative urine toxicology screen for marijuana, cocaine, opiates, amphetamines, phencyclidine, benzodiazepines, and barbiturates for screening and on the day of admission to the inpatient phase.
• Negative urine toxicology screen for nicotine (Cotinine) for screening and on the day of admission to the inpatient phase.
• Negative breath alcohol screen and agreement not to consume alcohol for the duration of the study.
• Body mass index (BMI) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2 [weight (kg)]/ [height (m)2].
• Agreement by subjects with reproductive potential to use highly effective contraception as described in protocol Section 4.1.1.
• Willingness to avoid strenuous exercise for at least 72 hours prior to initial study drug administration and during the study to Day 7 visit.
• Note: Strenuous physical exercise includes long distance running > 5 km/day, weight lifting, or any physical activity to which the subject is not accustomed.

You may not qualify if…

• Subjects meeting any of the Exclusion Criteria at Baseline will be excluded from study participation.
• Medical conditions that preclude participation in the study as determined by the study physician investigators.
• Note: Condition that may preclude participation includes:
• 1. Vital signs that are outside the ranges in the table below, measured after at least 10 minutes rest:
• Blood Pressure (BP) 90-140/55-90 mmHg Pulse Rate (PR) 50 100 beats/min Tympanic Temperature (T) less than or equal to 37.6ºC Respiration Rate (RR) 12 to 20 breaths/minute
• 2. Current diagnosis of pulmonary disease 1.3. Current diagnosis of asthma, which has required use of asthma medications within the past year 1.4. History of or current diagnosis of diabetes mellitus 1.5. Autoimmune disorder, such as systemic lupus erythematosus, Wegener's granulomatosis, rheumatoid arthritis 1.6. History of malignancy except low-grade skin cancer (i.e., basal cell carcinoma which has been surgically cured) 1.7. Chronic renal, hepatic, or pulmonary disease or gastrointestinal tract condition that could interfere with the absorption of the study drug (e.g., surgical resection of significant proportions of the stomach or bowel, gastric bypass, gastric banding, cholecystectomy, irritable bowel syndrome, inflammatory bowel disease) 1.8. History of cardiac abnormalities including Wolff-Parkinson-White syndrome, dysrhythmias, or coronary artery disease 1.9. History of prolonged QT interval
• Clinically significant abnormal electrocardiogram (ECG) at screening in the judgment of the investigator.
• Screening laboratory values outside the acceptable low and upper limits unless deemed NCS by the principal investigator or sub-investigator.
• Positive serology results for Hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) antibodies
• Febrile illness with temperature documented >38°C within 7 days of dosing
• Pregnancy or breastfeeding
• Known hypersensitivity or allergic reaction(s) to study drug components, including ingredients present in the formulation and/or to other nucleoside analogue antiviral drugs.
• Have consumed any prohibited products or undergone any prohibited procedure listed in Table 3 within the indicated time frame.
• Lack of ability to fully understand the informed consent. This will be determined by the recruiter/interviewer after explaining the consent and observing the subject reading the consent.
• Use of any form of tobacco, including cigarette smoking, pipe smoking, oral tobacco, for 30 days before screening and for the duration of the study.
• Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety.

Where it is running

• Georgetown University Hospital — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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