A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single Doses of Q203 in Normal, Healthy, Male and Female Volunteers

NCT02530710 | Completed Phase 1

• 1 other identifier: Q203-TB-PI-US001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1 - 7) of 8 subjects each, to receive either Q203 or placebo (6 active treatment : 2 placebo) in a fasting state. Dose escalation to the next cohort may be considered when at least 6 out of 8 subjects, in a cohort, completes all procedures and none of the subjects has a clinically significant adverse event (AE) that is being followed, or at the discretion of the PI if no drug-related serious adverse events (SAEs) have occurred. A food effect cohort will be enrolled to test administration of Q203 in a fed state, at 100 mg dose level (this dose level may change based on PK analysis results). Subjects who received 100mg dose in a fasting state will return and receive the second dose, with food. Subjects will be followed up for AEs, SAE or pregnancy for 30 days postdrug administration.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Safety assessed through adverse events, vital signs, ECG, laboratory results, and telemetry monitoring

  7 days post dose

Secondary Outcomes (3)

• Pharmacokinetic analysis: Area under the plasma concentration

  predose and 1, 2, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 216 and 312 hours postdose

• Pharmacokinetic analysis: Maximum observed plasma drug concentration

  predose and 1, 2, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 216 and 312 hours postdose

• Pharmacokinetic analysis: Time of maximum observed concentration

  predose and 1, 2, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 216 and 312 hours postdose

Study Arms (2)

Q203

EXPERIMENTAL

Q203 drug products (10mg and 100mg tablets)

Drug: Q203

Placebo

PLACEBO COMPARATOR

Placebo tablets (same excipients used in Q203 drug products)

Drug: Placebo

Interventions

Q203 DRUG

Q203

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to understand and sign an informed consent form.
• Healthy adult males and females of non-childbearing potential, ages 18 to 55 years, inclusive at the time of screening.
• Body mass index of 18 to 32 kg/m2, inclusive, and weighing at least 50 kg.
• Female subjects must be of non-childbearing potential (postmenopause or surgical sterilization). Postmenopausal status will be confirmed by a follicle-stimulating hormone (FSH) test at screening.
• Male subjects must agree to use a condom with spermicide when engaging in sexual intercourse during the study period and for 30 days after study drug dosing, if they have not had a vasectomy at least 6 months before study start.
• Male subjects must not donate sperm during the study and for 30 days after study drug dosing.
• Able to understand and comply with all of the study requirements.
• Able to swallow 8 tablets in succession.
• Willing to fast a minimum of 8 hours before check-in.
• Agree not to donate blood, plasma, platelets or any other blood components for 1 month after receiving study drug.
• Willing to abstain from alcohol use from 48 hours before check-in through the end of the study.
• Willing to forgo sunbathing and prolonged exposure to sunlight during the study period.
• Willing to forgo strenuous exercise during the study period.

You may not qualify if:

• Any known chronic systemic viral infection (including a positive serological test for HIV, HBsAg or HCAb that indicates infection).
• History of or current active tuberculosis (TB).
• Any systemic infection or other systemic illness, including persistent cough, respiratory, or flu-like symptoms, in the previous 30 days before screening.
• History of histoplasmosis, coccidioidomycosis, or similar opportunistic fungal infection.
• Vaccination in the previous 30 days before screening.
• History of, or clinically significant evidence of, bradycardia, syncope, or ECG abnormality or any other cardiovascular abnormality.
• Resting heart rate (HR) during screening or baseline ECG fewer than 50 beats per minute (bpm).
• History of seizures.
• History of drug (including amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidines, and cannabinoids) or alcohol abuse or addiction within the past 2 years or, if male, consumes more than 28 units of alcohol per week or, if female, consumes more than 21 units of alcohol per week (1 unit of alcohol equals 250 mL of beer, 100 mL of wine, or 25 mL of spirits).
• Any history of abnormal pulmonary function (e.g., asthma or related respiratory illnesses).
• Current or recent (within the past 3 months) use of tobacco or other nicotine-containing product or positive results for nicotine testing at screening or check-in.
• Use of any prescription or over-the-counter (OTC) drug or herbal product within 14 days before dosing.
• Use of any known drug metabolism enzyme-altering drug (inducers or inhibitors) or supplement (e.g., St. John's wort) within 14 days before dosing or consumption of foods or beverages containing alcohol or grapefruit within 48 hours before dosing.
• Use of any QT-prolonging agents, including, but not limited to, azithromycin, bepridil chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide dofetilide, domperidone, droperidol, erythromycin, Halofantrine, haloperidol, ibutilide, levomethadyl, lumefantrine, mefloquine, mesoridazine, methadone, moxifloxacin, pentamidine, pimozide, procainamide, quinidine, quinine, roxithromycin, sotalol, sparfloxacin, terfenadine, or thioridazine, from within 28 days before dosing through end of study.
• Any prior exposure to Q203 or participation in another investigational drug study within the previous 30 days before screening.

Sponsors & Collaborators

• Qurient Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

telacebec

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 21, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-08

Locations

US (1)