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LYT-300 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05129865
Recruitment Status : Completed
First Posted : November 22, 2021
Last Update Posted : November 13, 2023
Sponsor:
Collaborator:
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
PureTech

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: LYT-300 Other: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description:

Parts 1, 2 and 3 are double blind during the data collection. Determination for dose escalation may be made under unblinded conditions by assessors.

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.

Primary Purpose: Treatment
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
Actual Study Start Date : December 7, 2021
Actual Primary Completion Date : October 18, 2023
Actual Study Completion Date : October 23, 2023

Arm Intervention/treatment
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
Drug: LYT-300
A prodrug of allopregnanolone, a small molecule drug

Other: Placebo
Placebo for LYT-300

Experimental: LYT-300 in healthy volunteers LYT-300
LYT-300, Dose TBD with and without food, separated by 7-day washout
Drug: LYT-300
A prodrug of allopregnanolone, a small molecule drug

Experimental: LYT-300, Dose TBD QAM every 24 h for 7 days Drug: LYT-300
A prodrug of allopregnanolone, a small molecule drug

Placebo Comparator: Placebo QAM every 24 h for 7 days Other: Placebo
Placebo for LYT-300

Placebo Comparator: Placebo QHS every 24 h for 7 days Drug: LYT-300
A prodrug of allopregnanolone, a small molecule drug

Other: Placebo
Placebo for LYT-300

Experimental: LYT-300 in healthy volunteers LYT-300, Dose TBD QHS every 24 h for 7 days Drug: LYT-300
A prodrug of allopregnanolone, a small molecule drug

Other: Placebo
Placebo for LYT-300

Experimental: LYT-300 Drug: LYT-300
A prodrug of allopregnanolone, a small molecule drug

Placebo Comparator: Placebo Other: Placebo
Placebo for LYT-300




Primary Outcome Measures :
  1. 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.

  2. 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

  3. Salivary cortisol [ Time Frame: 60 minutes ]
    Change in salivary cortisol


Secondary Outcome Measures :
  1. Use pharmacokinetics to characterize the blood plasma concentration of allopregnanolone after administration of LYT-300 [ Time Frame: 7 days (main time frame) ]
    Measure the blood plasma concentrations of allopregnanolone in healthy volunteers after single and multiple doses of LYT-300 administered up to 7 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Main Inclusion Criteria:

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05129865


Locations
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Australia, South Australia
CMAX
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
PureTech
Novotech (Australia) Pty Limited
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Responsible Party: PureTech
ClinicalTrials.gov Identifier: NCT05129865    
Other Study ID Numbers: LYT-300-2021-101
First Posted: November 22, 2021    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No