Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers
ConditionHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTraws Pharma, Inc.
About this trial
This is a Phase 1b, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and food effect of single oral doses of TRX-100 tablets and capsules in healthy adult volunteers. Up to 32 participants will be enrolled in four cohorts and randomized within each cohort to receive TRX-100 or matching placebo.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
Adult males and females, 18 to 65 years of age (inclusive) at screening.
Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2, with a body weight (to 1 decimal place) ≥ 50.0 kg at screening.
Physical examination without any clinically significant findings in the opinion of the investigator.
Disqualifiers
History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant.
History of surgery or hospitalisation within 30 days prior to screening, or surgery planned during the study.
Acute infections within 4 weeks prior to screening or current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications.
Presence or history of any abnormality or illness, including gastrointestinal surgery, liver, kidney, or other conditions, which in the opinion of the PI may affect absorption, distribution, metabolism or elimination of the study drug.
Trial design
Design model
Sequential
Treatments tested in this trial
TRX-100
DrugTRX-100 will be administered as a single oral dose on Day 1 with approximately 240 mL of noncarbonated room-temperature water. Active treatment is administered as 240 mg tablets in Cohort A, 480 mg tablets in Cohorts B and C, and 480 mg capsules in Cohort D. Study drug must be swallowed whole and must not be chewed, divided, dissolved, or crushed.
Placebo
DrugMatching tablet or capsule placebo will be administered as a single oral dose on Day 1 under the same meal and administration conditions as the corresponding active-treatment cohort.
Treatment groups
32 Participants
are divided into 4 treatment groupsGroup A: Cohort A: 240 mg tablets, fedExperimental treatment 2 interventions
Group B: Cohort B: 480 mg tablets, fastedExperimental treatment 2 interventions
Group C: Cohort C: 480 mg tablets, fedExperimental treatment 2 interventions
Group D: Cohort D: 480 mg capsules, fedExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence, severity, and relationship of treatment-emergent adverse events
Number and percentage of participants with treatment-emergent adverse events, summarized by severity and relationship to study drug.
Time frame
From administration of study drug on Day 1 through the end-of-study visit on Day 28 (±2 days).2
Incidence of serious adverse events and adverse events leading to discontinuation
Number and percentage of participants with serious adverse events and adverse events leading to discontinuation from the study.
Time frame
From administration of study drug on Day 1 through the end-of-study visit on Day 28 (±2 days).Secondary outcomes
1
Maximum observed plasma concentration (Cmax) of TRX-100 and TRX-101
Maximum observed plasma concentration of TRX-100 and its active metabolite TRX-101.
Time frame
Predose through Day 28 (648 hours post-dose; ±2 days).2
Time to maximum observed plasma concentration (Tmax) of TRX-100 and TRX-101
Time to reach the maximum observed plasma concentration of TRX-100 and TRX-101.
Time frame
Predose through Day 28 (648 hours post-dose; ±2 days).3
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last)
AUC0-last of TRX-100 and TRX-101.
Time frame
Predose through Day 28 (648 hours post-dose; ±2 days).4
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24)
AUC0-24 of TRX-100 and TRX-101.
Time frame
Predose through 24 hours post-dose.Sponsors and contacts
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Source ClinicalTrials.gov