Clinical trial · Interventional
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Formulations and Doses of PWT-143
Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of Various Formulations of PWT-143 in Healthy Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This single center first in human (FIH) study will comprise 2 parts; Part 1 will consist of 3 sequential dose groups (Groups A, B and C) and Part 2 will consist of 1 dose group (Group A). There will be an option to include 2 additional dose groups in Part 1 (Groups D and E) to assess alternative dose levels or formulations, if required. In each study part, each subject will receive a single dose of investigational medicinal product PWT-143 in each of 2 study periods (total of 2 single doses).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PWT-143 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1
- description
- 3 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.
- interventionNames
- Drug: PWT-143
- type
- EXPERIMENTAL
- label
- Part 2
- description
- Single dose, 2-way crossover design to assess a selected formulation of PWT-143 in the fed and fasted states in 8 subjects.
- interventionNames
- Drug: PWT-143
Primary outcomes (1)
- measure
- The number of participants with and types of Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 conditions or surgery (eg, cholecystectomy) that could affect their ability to eat the high fat breakfast 5. Must be willing and able to communicate and participate in the whole study 6. Must be willing to provide voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care 7. Must agree to use an adequate method of contraception Exclusion 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 conditions or surgery (eg, cholecystectomy) that could affect their ability to eat the high fat breakfast 5. Must be willing and able to communicate and participate in the whole study 6. Must be willing to provide voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care 7. Must agree to use an adequate method of contraception
References
Publications (1)
- DERIVEDMoreno O, Butler T, Zann V, Willson A, Leung P, Connor A. Safety, Pharmacokinetics, and Pharmacodynamics of ME-401, an Oral, Potent, and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110delta, Following Single Ascending Dose Administration to Healthy Volunteers. Clin Ther. 2018 Nov;40(11):1855-1867. doi: 10.1016/j.clinthera.2018.09.006. Epub 2018 Oct 26. PMID 30458930