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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05129865




Registration number
NCT05129865
Ethics application status
Date submitted
31/10/2021
Date registered
22/11/2021
Date last updated
13/11/2023

Titles & IDs
Public title
LYT-300 in Healthy Volunteers
Scientific title
A Phase 1, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LYT-300 in Healthy Volunteers, and a Phase 1b/2a Study Part to Assess Effects of a Single Dose of LYT-300 vs. Placebo on the Response to a Standardized Behavioural Challenge in Healthy Volunteers
Secondary ID [1] 0 0
LYT-300-2021-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LYT-300
Other interventions - Placebo

Experimental: 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

Experimental: LYT-300 in healthy volunteers LYT-300 - LYT-300, Dose TBD with and without food, separated by 7-day washout

Experimental: LYT-300, Dose TBD QAM every 24 h for 7 days -

Placebo Comparator: Placebo QAM every 24 h for 7 days -

Placebo Comparator: Placebo QHS every 24 h for 7 days -

Experimental: LYT-300 in healthy volunteers LYT-300, Dose TBD QHS every 24 h for 7 days -

Experimental: LYT-300 -

Placebo Comparator: Placebo -


Treatment: Drugs: LYT-300
A prodrug of allopregnanolone, a small molecule drug

Other interventions: Placebo
Placebo for LYT-300
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability: treatment-emergent adverse events [TEAEs]
Timepoint [1] 0 0
7 days (main time frame)
Primary outcome [2] 0 0
Effect of food in healthy volunteers
Timepoint [2] 0 0
2 days (main time frame)
Primary outcome [3] 0 0
Salivary cortisol
Timepoint [3] 0 0
60 minutes
Secondary outcome [1] 0 0
Use pharmacokinetics to characterize the blood plasma concentration of allopregnanolone after administration of LYT-300
Timepoint [1] 0 0
7 days (main time frame)

Eligibility
Key inclusion criteria
Main

Parts 1, 2, 3 and 4: Healthy Volunteers

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.

Main
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parts 1, 2, 3 and 4: Healthy Volunteers

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/10/2023
Sample size
Target
Accrual to date
Final
186
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
PureTech
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Part 1 is a single ascending dose (SAD) trial in healthy volunteers (HV) to assess the
safety, tolerability, and pharmacokinetic (PK) profile of orally administered LYT-300.

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05129865
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05129865