LYT-300 in Healthy Volunteers

PureTech Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: LYT-300; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05129865

LYT-300-2021-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 8 patient groups, including a placebo group

LYT-300 in healthy volunteers LYT-300, Doses TBD

Experimental group

Description:

Subjects will crossover across 3 dosing periods in which they will receive placebo and two experimental dose levels

Treatment:

Other: Placebo

Drug: LYT-300

LYT-300 in healthy volunteers LYT-300

Experimental group

Description:

LYT-300, Dose TBD with and without food, separated by 7-day washout

Treatment:

Drug: LYT-300

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

Experimental group

Treatment:

Drug: LYT-300

Placebo QAM every 24 h for 7 days

Placebo Comparator group

Treatment:

Other: Placebo

Placebo QHS every 24 h for 7 days

Placebo Comparator group

Treatment:

Other: Placebo

Drug: LYT-300

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

Experimental group

Treatment:

Other: Placebo

Drug: LYT-300

LYT-300

Experimental group

Treatment:

Drug: LYT-300

Placebo

Placebo Comparator group

Treatment:

Other: Placebo