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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COMPLETED
PHASE1/PHASE2
186 participants
INTERVENTIONAL
2021-12-07
2023-10-23
Brief Summary
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Part 2 is a crossover assessment in HV of the effects of food on the safety, tolerability, and PK profile of orally administered LYT-300.
Part 3 is a multiple ascending dose (MAD) trial in HV to assess the safety, tolerability, and PK profile of multiple doses (up to 7 days) of orally administered LYT-300.
Part 4 is an assessment of the effects of LYT-300 vs. placebo on pharmacodynamic and patient reported outcome response to a validated clinical model of anxiety.
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Detailed Description
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Part 2: This is a randomized, open label, 3-period, 3-sequence, crossover assessment of the effects of food on the PK, safety, and tolerability of orally administered LYT-300 in HV. A single dose of LYT-300 will be administered on 3 occasions, separated by a minimum 7-day washout period. Part 2 is planned as a single dosing cohort.
Part 3: This is a randomized, double-blind, placebo-controlled, sequential, MAD trial in HV to assess the safety, tolerability, and PK profile of multiple doses (up to 7 days) of orally administered LYT-300. This part will include ascending doses given either once daily in the morning (QAM), once daily in the evening (QHS), or twice daily (BID).
Part 4: This is a double-blind, randomized assessment of the effects in HV of a single dose of LYT-300 vs. placebo on pharmacodynamic and patient reported outcome response to a validated clinical model of anxiety.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Part 4 consists of 2 groups. Group 1 (the validation group) will be single-arm placebo. Group 2 (the test group) will be double blind during data collection.
Study Groups
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LYT-300 in healthy volunteers LYT-300, Doses TBD
Subjects will crossover across 3 dosing periods in which they will receive placebo and two experimental dose levels
LYT-300
A prodrug of allopregnanolone, a small molecule drug
Placebo
Placebo for LYT-300
LYT-300 in healthy volunteers LYT-300
LYT-300, Dose TBD with and without food, separated by 7-day washout
LYT-300
A prodrug of allopregnanolone, a small molecule drug
LYT-300, Dose TBD QAM every 24 h for 7 days
LYT-300
A prodrug of allopregnanolone, a small molecule drug
Placebo QAM every 24 h for 7 days
Placebo
Placebo for LYT-300
Placebo QHS every 24 h for 7 days
LYT-300
A prodrug of allopregnanolone, a small molecule drug
Placebo
Placebo for LYT-300
LYT-300 in healthy volunteers LYT-300, Dose TBD QHS every 24 h for 7 days
LYT-300
A prodrug of allopregnanolone, a small molecule drug
Placebo
Placebo for LYT-300
LYT-300
LYT-300
A prodrug of allopregnanolone, a small molecule drug
Placebo
Placebo
Placebo for LYT-300
Interventions
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LYT-300
A prodrug of allopregnanolone, a small molecule drug
Placebo
Placebo for LYT-300
Eligibility Criteria
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Inclusion Criteria
1. Male or female between 18 and 55 years old (inclusive) at the time of screening.
2. In good general health at screening, free from clinically significant unstable medical, surgical or psychiatric illness, at the discretion of the Investigator.
Exclusion Criteria
1. Evidence or history of any condition or situation that adversely impacts a normal sleep-wake cycle.
2. Confirmed COVID-19 infection within 2 months of screening, known exposure to another person with COVID-19 within 14 days of screening
3. History of illness with fever within 28 days prior to the first dose.
4. A history of, or current evidence for, serious mental illness
18 Years
55 Years
ALL
Yes
Sponsors
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Novotech (Australia) Pty Limited
INDUSTRY
PureTech
INDUSTRY
Responsible Party
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Locations
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CMAX
Adelaide, South Australia, Australia
Countries
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Other Identifiers
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LYT-300-2021-101
Identifier Type: -
Identifier Source: org_study_id
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