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PWT-143

Phase 1

Malignancies | Small molecule | Oncology |Lite Strategy, Inc.|Last Updated: Aug 29, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

PWT-143 · 1 trial · 1 indication

Phase 1 1
NCT02521389Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Formulations and Doses of PWT-143Malignancies
COMPLETED35 Analytics
PHASE1COMPLETED
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Formulations and Doses of PWT-143
MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

The number of participants with and types of Adverse Events
5 months

Secondary Endpoints

Tmax (time from dosing at which Cmax is determined)
5 months
Cmax (maximum observed plasma concentration)
5 months
AUC (area under the concentration time curve)
5 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Part 1EXPERIMENTAL3 sequential groups (Groups A, B and C), comprising 3, 6 and 6 subjects, respectively, with 2 optional additional groups (Groups D and E), each comprising 6 subjects, to assess alternative dose levels or formulations (described below), if required.
Part 2EXPERIMENTALSingle dose, 2-way crossover design to assess a selected formulation of PWT-143 in the fed and fasted states in 8 subjects.

Interventions

NameTypeDescription
PWT-143DRUGphosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) delta inhibitor
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy males 2. Age 18 to 65 years of age 3. Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator 4. Part 2 only: Must be able to consume all food items in a standard high fat breakfast and/or have no condi...

Countries:United Kingdom
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Frequently asked questions about PWT-143

What is PWT-143 used for?

PWT-143 is an investigational small molecule being developed for the treatment of malignancies, which are cancers or tumors. It is currently in Phase 1 clinical development, meaning it is being studied for safety and tolerability in humans. It is not yet approved by regulatory authorities.

Who makes PWT-143?

PWT-143 is being developed by Lite Strategy, Inc., a company traded under the ticker symbol LITS. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with malignancies.

What phase is PWT-143 in?

PWT-143 is in Phase 1 clinical development. A Phase 1 trial has been completed, which assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of various formulations and doses of the drug in patients with malignancies.

What clinical trials is PWT-143 in?

PWT-143 has one completed Phase 1 clinical trial, identified as NCT02521389. This trial assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of various formulations and doses of PWT-143 in patients with malignancies. The trial enrolled 35 participants in the United Kingdom.

Is PWT-143 the same as any other drug?

No alternative names for PWT-143 have been reported. It is identified solely by its code name PWT-143 in clinical trial registries and development programs.