Healthy VolunteersPhase 1/2NCT05129865

LYT-300 in Healthy Volunteers

A Phase 1/2 study testing LYT-300 in people with Healthy Volunteers, run by PureTech at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: LYT-300
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 186 participants
Where: 1 siteAustralia
Study dates: 7 Dec 2021to 23 Oct 2023
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Main Inclusion Criteria:

Parts 1, 2, 3 and 4: Healthy Volunteers

Male or female between 18 and 55 years old (inclusive) at the time of screening.
In good general health at screening, free from clinically significant unstable medical, surgical or psychiatric illness, at the discretion of the Investigator.

Main Exclusion Criteria:

Parts 1, 2, 3 and 4: Healthy Volunteers

Evidence or history of any condition or situation that adversely impacts a normal sleep-wake cycle.
Confirmed COVID-19 infection within 2 months of screening, known exposure to another person with COVID-19 within 14 days of screening
History of illness with fever within 28 days prior to the first dose.
A history of, or current evidence for, serious mental illness

Trial locations and contacts

1 site in 1 country.

Australia1 site

CMAX
Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official 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

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.

Read the detailed description

Part 1: This is a randomized, double-blind, placebo-controlled, SAD design to assess the safety, tolerability, and PK profile of orally administered LYT-300 in HV, in a 3-period, 3-sequence, crossover, dose escalation design.

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: Healthy Volunteers
Being tested: LYT-300, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LYT-300Drug
A prodrug of allopregnanolone, a small molecule drug
PlaceboOther
Placebo for LYT-300

Study groups in NCT05129865
Study group	Role	What they receive
LYT-300 in healthy volunteers LYT-300, Doses TBD	Experimental	Subjects will crossover across 3 dosing periods in which they will receive placebo and two experimental dose levels Receives: Drug: LYT-300; Other: Placebo
LYT-300 in healthy volunteers LYT-300	Experimental	LYT-300, Dose TBD with and without food, separated by 7-day washout Receives: Drug: LYT-300
LYT-300, Dose TBD QAM every 24 h for 7 days	Experimental	Not described Receives: Drug: LYT-300
Placebo QAM every 24 h for 7 days	Placebo comparator	Not described Receives: Other: Placebo
Placebo QHS every 24 h for 7 days	Placebo comparator	Not described Receives: Drug: LYT-300; Other: Placebo
LYT-300 in healthy volunteers LYT-300, Dose TBD QHS every 24 h for 7 days	Experimental	Not described Receives: Drug: LYT-300; Other: Placebo
LYT-300	Experimental	Not described Receives: Drug: LYT-300
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability: treatment-emergent adverse events [TEAEs]
Evaluate the safety and tolerability in healthy volunteers following single or multiple oral doses of LYT-300 as measured by TEAEs.
Measured: 7 days (main time frame)
Effect of food in healthy volunteers
Measure concentration of allopregnanolone in blood plasma in fed or fasted subjects administered a single dose of LYT-300
Measured: 2 days (main time frame)
Salivary cortisol
Change in salivary cortisol
Measured: 60 minutes

Secondary outcomes (1)

Use pharmacokinetics to characterize the blood plasma concentration of allopregnanolone after administration of LYT-300
Measure the blood plasma concentrations of allopregnanolone in healthy volunteers after single and multiple doses of LYT-300 administered up to 7 days
Measured: 7 days (main time frame)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 202123 Oct 2023

First posted22 Nov 2021
Study start7 Dec 2021
Primary completion18 Oct 2023
Study completion23 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Part 1 consists of 1 Arm with crossover of active treatment and placebo; Part 2 consists of 1 Arm with active treatment; Part 3 consists of 4 Arms with active treatment or placebo; Part 4 consists of 2 arms with active or placebo.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05129865
Sponsor's protocol ID: LYT-300-2021-101
Status last verified: Nov 2022
First submitted: 31 Oct 2021
Last updated: 13 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT05129865
Acronym / sponsor ID: LYT-300-2021-101
Conditions: Healthy Volunteers
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 186 participants (actual)
Lead sponsor: PureTechIndustry (pharma, biotech, devices)
Collaborators: Novotech (Australia) Pty Limited
Study start: 7 Dec 2021 (actual)
Primary completion: 18 Oct 2023 (actual)
Study completion: 23 Oct 2023 (actual)
First posted: 22 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8
Model description: Part 1 consists of 1 Arm with crossover of active treatment and placebo; Part 2 consists of 1 Arm with active treatment; Part 3 consists of 4 Arms with active treatment or placebo; Part 4 consists of 2 arms with active or placebo.

Arm	Type	Receives
LYT-300 in healthy volunteers LYT-300, Doses TBD	Experimental	Drug: LYT-300, Other: PlaceboSubjects will crossover across 3 dosing periods in which they will receive placebo and two experimental dose levels
LYT-300 in healthy volunteers LYT-300	Experimental	Drug: LYT-300LYT-300, Dose TBD with and without food, separated by 7-day washout
LYT-300, Dose TBD QAM every 24 h for 7 days	Experimental	Drug: LYT-300
Placebo QAM every 24 h for 7 days	Placebo comparator	Other: Placebo
Placebo QHS every 24 h for 7 days	Placebo comparator	Drug: LYT-300, Other: Placebo
LYT-300 in healthy volunteers LYT-300, Dose TBD QHS every 24 h for 7 days	Experimental	Drug: LYT-300, Other: Placebo
LYT-300	Experimental	Drug: LYT-300
Placebo	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LYT-300A prodrug of allopregnanolone, a small molecule drug	Drug	LYT-300, LYT-300 in healthy volunteers LYT-300, LYT-300 in healthy volunteers LYT-300, Dose TBD QHS every 24 h for 7 days, LYT-300 in healthy volunteers LYT-300, Doses TBD, LYT-300, Dose TBD QAM every 24 h for 7 days, Placebo QHS every 24 h for 7 days
PlaceboPlacebo for LYT-300	Other	LYT-300 in healthy volunteers LYT-300, Dose TBD QHS every 24 h for 7 days, LYT-300 in healthy volunteers LYT-300, Doses TBD, Placebo, Placebo QAM every 24 h for 7 days, Placebo QHS every 24 h for 7 days

Primary outcome

Safety and tolerability: treatment-emergent adverse events [TEAEs]
Time frame: 7 days (main time frame)
Evaluate the safety and tolerability in healthy volunteers following single or multiple oral doses of LYT-300 as measured by TEAEs.
Effect of food in healthy volunteers
Time frame: 2 days (main time frame)
Measure concentration of allopregnanolone in blood plasma in fed or fasted subjects administered a single dose of LYT-300
Salivary cortisol
Time frame: 60 minutes
Change in salivary cortisol

1 secondary outcome

Use pharmacokinetics to characterize the blood plasma concentration of allopregnanolone after administration of LYT-300
Time frame: 7 days (main time frame)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LYT-300 in people with Healthy Volunteers, run by PureTech at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability: treatment-emergent adverse events [TEAEs] (time frame: 7 days (main time frame)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05129865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.