LYT-300 in Healthy Volunteers

NCT05129865 | Completed Phase 1 DMC

• 1 other identifier: LYT-300-2021-101
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  2 days (main time frame)

• Salivary cortisol

  Change in salivary cortisol

  60 minutes

Secondary Outcomes (1)

• Use pharmacokinetics to characterize the blood plasma concentration of allopregnanolone after administration of LYT-300

  7 days (main time frame)

Study Arms (8)

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

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

Drug: LYT-300

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

Interventions

LYT-300 DRUG

A prodrug of allopregnanolone, a small molecule 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

Placebo OTHER

Placebo for 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; Placebo; Placebo QAM every 24 h for 7 days; Placebo QHS every 24 h for 7 days

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PureTech: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

CMAX

Adelaide, South Australia, 5000, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: November 22, 2021
• Study Start: December 7, 2021
• Primary Completion: October 18, 2023
• Study Completion: October 23, 2023
• Last Updated: November 13, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)