This study is a randomized, double-blind, placebo-controlled clinical trial featuring both single ascending dose (SAD), food effect and multiple ascending dose (MAD) phases intended to evaluate the safety, tolerability, PK, PD, and active metabolites of LWP779 after oral administration in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
Active
Placebo
CMAX Clinical Research Pty Ltd
Adelaide, Australia
RECRUITINGNumber and proportion of participants with a treatment-emergent adverse event (TEAE)
Time frame: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
12-lead electrocardiogram (ECG) (QT Interval)
Time frame: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
Number of participants with abnormal vital signs
Time frame: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
Number of participants with abnormal physical examination findings
Time frame: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
Columbia Suicide Severity Rating Scale (C-SSRS)
The Columbia Suicide Severity Rating Scale (C-SSRS) is used to assess suicidal ideation and suicidal behavior. Within the module "Answer for Actual Suicidal Attempts Only", the scoring range is 0 to 5. A score of 0 indicates no physical damage or very minor physical damage (e.g. surface scratches), and a score of 5 indicates death.
Time frame: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
Number of participants with abnormal laboratory tests results
Time frame: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
Number of participants with abnormal ophthalmoscopic-examination findings
Time frame: From baseline to Day 7 (±1) for SAD, baseline to Day16 (±2) for FE, baseline to Day 14 (± 2) for MAD
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
C-QTc in the dose escalation part of SAD(in the dose groups of ≥300 mg)
Time frame: Wthin 30 minutes before administration and to 24 hours after administration.
Maximum concentration (Cmax) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Time to reach Cmax (Tmax) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Total area under the concentration time curve (AUC) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Apparent terminal half-life (t1/2) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Terminal elimination rate constant (λz) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Apparent clearance (CL/F) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Apparent volume of distribution divided by bioavailability (Vd/F) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Lag time (tlag) of LWP779 and its active metabolites in plasma
Time frame: Within 30 minutes before administration to 48 hours after single administration
Steady-state minimum concentration (Cmin,ss) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Steady-state maximum concentration (Cmax,ss) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Steady-state average concentration (Cavg,ss) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Area under the concentration-time curve from time zero to tau (AUC0-τ) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Time to reach Cmax (Tmax) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Terminal elimination rate constant (λz) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Apparent terminal half-life (t1/2) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Accumulation index (AUC0-τ (D7) / AUC0-τ (D1)) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.
Cmax (D7) / Cmax (D1)) of LWP779 and its active metabolites in plasma
Time frame: Wthin 30 minutes before administration to 24 hours after multiple administration on Day 1 and Day 7, and 30 min pre-dose on Day 5 and Day 6.