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| Name | Class |
|---|---|
| Fortrea | INDUSTRY |
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The goal of this clinical trial is to Assess the Effect of Food on the
Pharmacokinetics (PK) of D3S-001 in Healthy Adult Participants. The main question[s] it aims to answer are:
Potential participants will be screened within 28 days prior to the first dose. Participants will be admitted into the clinical research unit (CRU) on Day -1 and will be confined until end of study (EOS) or until early termination. On Day 1, participants will be randomised to Group 1 or Group 2. Participants will receive Treatment A or Treatment B in each of 2 periods (Periods 1 and 2; Study Days 1 and 4), once under fasted conditions (Treatment A) and once under fed conditions (Treatment B). Each participant will receive both treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Fasted and Fed | Experimental | Period 1 (day 1-3): Treatment A - 600mg D3S-001, following an overnight fast of at least 10 hours. Period 2 (day 4 to 6): Treatment B - 600mg D3S-001, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast. |
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| Group 2 - Fed and Fasted | Experimental | Period 1 (day 1-3): Treatment B - 600mg D3S-001, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast. Period 2 (day 4-6): Treatment A - 600mg D3S-001, following an overnight fast of at least 10 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D3S-001 | Drug | The investigational product dose: 600 mg D3S-001 capsules. A 600-mg oral dose of D3S-001 will be given to potential participants on Day 1 and Day 4. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) | Maximum Observed Concentration (Cmax) of D3S-001 administered in the fasted and fed state. | From screening to end of treatment at 34 days |
| Area under the concentration-time curve | Evaluate the area under the concentration-time curve from time zero to the time of the last quantifiable concentration after D3S-001 administered in the fasted and fed state. | From screening to end of treatment at 34 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Subjects will be observed for any signs or symptoms of adverse events and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit. | From screening to end of study (approximately 34 days) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Polasek, MD | CMAX Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research | Adelaide | South Australia | 5000 | Australia |
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This will be a Phase 1, single-centre, open-label, randomised, crossover study in healthy adult male and female participants. Potential participants will be screened within 28 days prior to the first dose. Participants will be admitted into the clinical research unit (CRU) on Day -1 and will be confined until end of study (EOS) or until early termination. On Day 1, participants will be randomised to Group 1 or Group 2. Participants will receive Treatment A or Treatment B in each of 2 periods (Periods 1 and 2; Study Days 1 and 4), once under fasted conditions (Treatment A) and once under fed conditions (Treatment B).
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| Number of clinically significant clinical laboratory findings |
Evaluate the safety and tolerability of the drug through clinical laboratory assessments, including clinical chemistry, haematology, coagulation, and urinalysis. |
| On Screening visit, Day -1, Days 2-3 and Days 5-6 (End of Study) |
| Number of clinically significant electrocardiogram parameters | Evaluate the safety and tolerability of the drug using resting 12-lead electrocardiogram (ECG) parameters, recorded after the subject has been supine and at rest for at least 5 minutes. The following ECG Measurements will be recorded: Heart Rate, RR Interval, PR Internal, QRSD QT Interval, QTcB and QTcF. | On screening day, Day -1 and Days 1-6 (End of Study) |
| To determine the safety and tolerability of the drug in healthy subjects, as assessed by the collection of vital signs. | Temperature in Degrees Celsius (℃) | On screening day, Day -1 and Days 1-6 (End of Study) |
| To determine the safety and tolerability of the drug in healthy subjects, as assessed by the collection of vital signs. | Pulse in beats per minute (bpm) | On screening day, Day -1 and Days 1-6 (End of Study) |
| To determine the safety and tolerability of the drug in healthy subjects, as assessed by the collection of vital signs. | Respiratory Rate in respirations per minute (rpm) | On screening day, Day -1 and Days 1-6 (End of Study) |
| To determine the safety and tolerability of the drug in healthy subjects, as assessed by the collection of vital signs. | Systolic and Diastolic Blood Pressure in millimeters of mercury (mmHg) | On screening day, Day -1 and Days 1-6 (End of Study) |
| Number of clinically significant physical examinations | Evaluate the safety and tolerability of the drug by performing HEENT [head, eyes, ears, nose, and throat], mouth/dental, neck [including thyroid & nodes], cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, skin, and other examinations. | On Screening visit, Day -1 and Day 6 (End of Study) |