A Phase 1 Study to Assess Food Effect on the Pharmacokinetics of D3S-001 in Healthy Adult Participants
NCT ID: NCT07093398
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
14 participants
INTERVENTIONAL
2025-07-11
2026-01-30
Brief Summary
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Pharmacokinetics (PK) of D3S-001 in Healthy Adult Participants. The main question\[s\] it aims to answer are:
1. Evaluate the PK of D3S-001 administered in the fasted and fed state in healthy adult participants.
2. Evaluate the safety and tolerability of D3S-001 administered in the fasted and fed state in healthy adult 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). Each participant will receive both treatments.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group 1 - Fasted and Fed
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.
D3S-001
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.
Group 2 - Fed and Fasted
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.
D3S-001
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.
Interventions
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D3S-001
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.
Eligibility Criteria
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Inclusion Criteria
* Males or females of any race, aged between 18 to 65 years, inclusive, with a body mass index between 18.0 and 32.0 kg/m2, inclusive.
* In good health, determined by no clinically significant findings.
Exclusion Criteria
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
* History of stomach or intestinal surgery (including but not limited to cholecystectomy) or resection that would potentially alter absorption and/or excretion of orally administered drugs.
* Unable or unwilling to consume the protocol-specified high-fat breakfast.
18 Years
65 Years
ALL
Yes
Sponsors
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Fortrea
INDUSTRY
D3 Bio (Wuxi) Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Polasek, MD
Role: PRINCIPAL_INVESTIGATOR
CMAX Clinical Research
Locations
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CMAX Clinical Research
Adelaide, South Australia, Australia
CMAX Clinical Research
Adelaide, South Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Jacqueline Stepien, B.Sc (Hons), Grad Dip Ed, PhD
Role: primary
Other Identifiers
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D3S-001-CP003
Identifier Type: -
Identifier Source: org_study_id
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