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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004187-26 | EudraCT Number |
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The study will investigate the effect of food on the Pharmacokinetic (PK) of a single dose of peposertib administered as film-coated tablet under fed and fasted conditions. Furthermore, the PK profile of peposertib administered as an oral suspension of disintegrated tablets and as film-coated tablets will be compared under fasted conditions to evaluate the relative bioavailability in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Peposertib: Treatment Sequence A-B-C | Experimental | Participants will receive single oral dose of peposertib tablet (Treatment A) on Day 1 under fasted condition in period 1, followed by single oral dose of peposertib tablet (Treatment B) on Day 8 under fed condition in period 2, followed by oral suspension dose of peposertib (Treatment C) on Day 15 under fasted condition in period 3. There will be washout period of 7 days between each treatment period. |
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| Part 1: Peposertib Treatment Sequence A-C-B | Experimental | Participants will receive single oral dose of peposertib tablet (Treatment A) on Day 1 under fasted condition in period 1, followed by oral suspension dose of peposertib (Treatment C) on Day 8 under fasted condition in period 2, followed by single oral dose of peposertib tablet (Treatment B) on Day 15 under fed condition in period 3. There will be washout period of 7 days between each treatment period. |
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| Part 1: Peposertib Treatment Sequence B-A-C | Experimental | Participants will receive single oral dose of peposertib tablet (Treatment B) on Day 1 under fed condition in period 1, followed by single oral dose of peposertib tablet (Treatment A) on Day 8 under fasted condition in period 2, followed by oral suspension dose of peposertib (Treatment C) on Day 15 under fasted condition in period 3. There will be washout period of 7 days between each treatment period. |
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| Part 1: Peposertib Treatment Sequence B-C-A | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peposertib | Drug | Participants will receive single oral dose of Peposertib tablet under fasting (Treatment A) or fed (Treatment B) conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Sampling (AUC0-tlast) of Peposertib | Pre-dose up to 36 hours post-dose | |
| Part 1 and Part 2: Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC-inf) of Peposertib | Pre-dose up to 36 hours post-dose | |
| Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) of Peposertib | Pre-dose up to 36 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Part 1: up to 21 days; Part 2: up to 14 days | |
| Part 1 and Part 2: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) Based on Severity According to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuvisan GmbH | Gauting | Germany | ||||
| Nuvisan GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37905356 | Derived | Becker A, Krebs-Brown A, Vetter C, Reuter T, Rodriguez-Gutierrez A, You X, Lissy M. Phase I crossover study of DNA-protein kinase inhibitor peposertib in healthy volunteers: Effect of food and pharmacokinetics of an oral suspension. Clin Transl Sci. 2023 Dec;16(12):2628-2639. doi: 10.1111/cts.13657. Epub 2023 Oct 31. |
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
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Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
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| ID | Term |
|---|---|
| C000716216 | peposertib |
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Participants will receive single oral dose of peposertib tablet (Treatment B) on Day 1 under fed condition in period 1, followed by oral suspension dose of peposertib (Treatment C) on Day 8 under fasted condition in period 2, followed by single oral dose of peposertib tablet (Treatment A) on Day 15 under fasted condition in period 3. There will be washout period of 7 days between each treatment period.
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| Part 1: Peposertib: Treatment Sequence C-A-B | Experimental | Participants will receive oral suspension dose of peposertib (Treatment C) on Day 1 under fasted condition in period 1, followed by single oral dose of peposertib tablet (Treatment A) on Day 8 under fasted condition in period 2, followed by single oral dose of peposertib tablet (Treatment B) on Day 15 under fed condition in period 3. There will be washout period of 7 days between each treatment period. |
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| Part 1: Peposertib Treatment Sequence C-B-A | Experimental | Participants will receive oral suspension dose of peposertib (Treatment C) on Day 1 under fasted condition in period 1, followed by single oral dose of peposertib tablet (Treatment B) on Day 8 under fed condition in period 2, followed by single oral dose of peposertib tablet (Treatment A) on Day 15 under fasted condition in period 3. There will be washout period of 7 days between each treatment period. |
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| Part 2: Peposertib Treatment Sequence A-B | Experimental | Participants will receive single oral dose of peposertib tablet (Treatment A) on Day 1 under fasted condition in period 1, followed by single oral dose of peposertib tablet (Treatment B) on Day 8 under fed condition in period 2. There will be washout period of 7 days between each treatment period. |
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| Part 2: Peposertib: Treatment Sequence B-A | Experimental | Participants will receive single oral dose of peposertib tablet (Treatment B) on Day 1 under fed condition in period 1, followed by single oral dose of peposertib tablet (Treatment A) on Day 8 under fasted condition in period 2. There will be washout period of 7 days between each treatment period. |
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| Peposertib | Drug | Participants will receive oral suspension dose of peposertib tablets under fasted condition (Treatment C) in either period 1, 2 or 3 of part 1. |
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| Part 1: up to 21 days; Part 2: up to 14 days |
| Part 1 and Part 2: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Findings | Number of participants with clinically significant change from baseline in laboratory parameters, vital signs and 12-Lead electrocardiogram (ECG) findings will be reported. | Part 1: up to 21 days; Part 2: up to 14 days |
| Neu-Ulm |
| Germany |
| Medical Information Location Map - Med Info Contacts | View source |