HealthyPhase 1NCT04702698

Effect of Food on Peposertib PK

A Phase 1 study testing Peposertib in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study investigated 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 was compared under… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Peposertib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteGermany
Study dates: 14 Jan 2021to 3 Mar 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
Participants are nonsmoker for at least 6 months prior to Screening
Participants have a body weight greater than 50 kilogram (kg) and a body mass index within the range 18.5 to 30.0 kilogram per meter square (inclusive) at Screening
Male participants are refrain from donating sperm plus either abstain from any activity that allows for exposure to ejaculate
Female participants are not pregnant or breastfeeding
Other protocol defined inclusion criteria could apply

Who cannot join

History of clinically relevant renal, cardiovascular, pulmonary disease, or endocrinology disorder at Screening
History of clinically relevant gastrointestinal disease, in particular pancreatic disease, cholecystitis, liver diseases or hepatic dysfunction at Screening
History of psychiatric or relevant neurological disorders (example, depression, epilepsy) at Screening
History of relevant skin and mucosal diseases (rash, mucositis) at Screening
Presence or history of any serious allergy (requiring hospitalization or prolonged systemic treatment) at Screening
Any planned radiologic assessments during the study conduct phase
Participants who are not able or willing to eat the entire study meals.
Other protocol defined exclusion criteria could apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

Nuvisan GmbH
Gauting

Other trials in Germany

About this study

Official title: Phase I, Open-Label, Randomized, Single-Dose Study With Crossover Design to Investigate the Effect of Food on the PK of Peposertib Tablet Formulation and to Investigate the PK of Peposertib Administered as Oral Suspension of Disintegrated Tablets

Conditions: Healthy
Being tested: Peposertib
Keywords: Peposertib, Pharmacokinetics, Relative Bioavailability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PeposertibDrug
Also called MSC2490484A, M3814
Participants received single oral dose of oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib under fasting (Treatment A) or fed (Treatment B) conditions in either of 3 treatment periods.
PeposertibDrug
Also called MSC2490484A, M3814
Participants received single oral dose of 100 mg (two 50 mg oral suspension) Peposertib (Treatment C) in either of 3 treatment periods under fasted conditions.

Study groups in NCT04702698
Study group	Role	What they receive
Part 1: Treatment Sequence 1: A - B - C	Experimental	Participants received single oral dose of 100 milligrams (mg) (two 50 mg film-coated tablets) Peposertib (Treatment A) on Day 1 under fasted condition in treatment period 1, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment B) on Day 8 under fed condition in treatment period 2, followed by single oral dose of 100 mg (two 50 mg oral suspension of disintegrated film-coated tablets) Peposertib (Treatment C) on Day 15 under fasted condition in treatment period 3. A washout period of 7 days was maintained between 3 treatment periods. Receives: Drug: Peposertib
Part 1: Treatment Sequence 2: A - C - B	Experimental	Participants received single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment A) on Day 1 under fasted condition in treatment period 1, followed by single oral dose of 100 mg (two 50 mg oral suspension of disintegrated film-coated tablets) Peposertib (Treatment C) on Day 8 under fasted condition in treatment period 2, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment B) on Day 15 under fed condition in treatment period 3. A washout period of 7 days was maintained between 3 treatment periods. Receives: Drug: Peposertib
Part 1: Treatment Sequence 3: B - A - C	Experimental	Participants received single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment B) on Day 1 under fed condition in treatment period 1, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment A) on Day 8 under fasted condition in treatment period 2, followed by single oral dose of 100 mg (two 50 mg oral suspension of disintegrated film-coated tablets) Peposertib (Treatment C) on Day 15 under fasted condition in treatment period 3. A washout period of 7 days was maintained between 3 treatment periods. Receives: Drug: Peposertib
Part 1: Treatment Sequence 4: B - C - A	Experimental	Participants received single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment B) on Day 1 under fed condition in treatment period 1, followed by single oral dose of 100 mg (two 50 mg oral suspension of disintegrated film-coated tablets) Peposertib (Treatment C) on Day 8 under fasted condition in treatment period 2, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment A) on Day 15 under fasted condition in treatment period 3. A washout period of 7 days was maintained between 3 treatment periods. Receives: Drug: Peposertib
Part 1: Treatment Sequence 5: C - A - B	Experimental	Participants received single oral dose of 100 mg (two 50 mg oral suspension of disintegrated film-coated tablets) Peposertib (Treatment C) on Day 1 under fasted condition in treatment period 1, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment A) on Day 8 under fasted condition in treatment period 2, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment B) on Day 15 under fed condition in treatment period 3. A washout period of 7 days was maintained between 3 treatment periods. Receives: Drug: Peposertib
Part 1: Treatment Sequence 6: C - B - A	Experimental	Participants received single oral dose of 100 mg (two 50 mg oral suspension of disintegrated film-coated tablets) Peposertib (Treatment C) on Day 1 under fasted condition in treatment period 1, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment B) on Day 8 under fed condition in treatment period 2, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment A) on Day 15 under fasted condition in treatment period 3. A washout period of 7 days was maintained between 3 treatment periods. Receives: Drug: Peposertib

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Sampling (AUC0-tlast) of Peposertib
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose and 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 12.0, 24.0 and 36.0 hours after post-dose in each treatment period
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Peposertib
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Measured: Pre-dose and 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 12.0, 24.0 and 36.0 hours after post-dose in each treatment period
Part 1: Maximum Observed Plasma Concentration (Cmax) of Peposertib
Cmax was obtained directly from the concentration versus time curve.
Measured: Pre-dose and 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 12.0, 24.0 and 36.0 hours after post-dose in each treatment period

Secondary outcomes (5)

Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether/not considered related to the study drug. Serious AE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE was defined as an AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs.
Measured: up to Day 7 of each treatment period
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale
Severity of TEAEs were graded using Qualitative Toxicity Scale selected from the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.
Measured: up to Day 7 of each treatment period
Part 1: Number of Participants With Clinically Relevant Changes From Baseline in Laboratory Parameters
Laboratory parameters included hematology, biochemistry and urinalysis. Clinical relevance was determined by the investigator. The number of participants with clinically relevant changes from baseline in laboratory parameters were reported.
Measured: up to Day 7 of each treatment period
Part 1: Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs
Vital signs included body temperature, systolic and diastolic blood pressure. Clinical relevance was determined by the investigator. The number of participants with clinically relevant changes from baseline in vital signs were reported.
Measured: up to Day 7 of each treatment period
Part 1: Number of Participants With Clinically Relevant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings
12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration and QT interval. The corrected QT interval (QTcF) was calculated using Fridericia's formula. 12-lead ECG recordings were obtained after the participants have rested for at least 5 minutes in semi-supine position. Clinical relevance was determined by the investigator. The number of participants with clinically relevant changes from baseline in 12-Lead ECG findings were reported.
Measured: up to Day 7 of each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 20213 Mar 2021

First posted11 Jan 2021
Study start14 Jan 2021
Primary completion3 Mar 2021
Study completion3 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04702698
Sponsor's protocol ID: MS100036_0040
Other IDs: 2020-004187-26
Status last verified: Aug 2026
First submitted: 7 Jan 2021
Last updated: 6 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.

Publications

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.
PubMed 37905356

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Open-Label, Randomized, Single-Dose Study With Crossover Design to Investigate the Effect of Food on the PK of Peposertib Tablet Formulation and to Investigate the PK of Peposertib Administered as Oral Suspension of Disintegrated Tablets
ClinicalTrials.gov ID: NCT04702698
Acronym / sponsor ID: MS100036_0040
Conditions: Healthy
Keywords: Peposertib, Pharmacokinetics, Relative Bioavailability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Study start: 14 Jan 2021 (actual)
Primary completion: 3 Mar 2021 (actual)
Study completion: 3 Mar 2021 (actual)
First posted: 11 Jan 2021 (actual)
Results: Posted 6 Nov 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Part 1: Treatment Sequence 1: A - B - C	Experimental	Drug: PeposertibParticipants received single oral dose of 100 milligrams (mg) (two 50 mg film-coated tablets) Peposertib (Treatment A) on Day 1 under fasted condition in treatment period 1, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment B) on Day 8 under fed condition in treatment period 2, followed by single oral dose of 100 mg (two 50 mg oral suspension of disintegrated film-coated tablets) Peposertib (Treatment C) on Day 15 under fasted condition in treatment period 3. A washout period of 7 days was maintained between 3 treatment periods.
Part 1: Treatment Sequence 2: A - C - B	Experimental	Drug: PeposertibParticipants received single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment A) on Day 1 under fasted condition in treatment period 1, followed by single oral dose of 100 mg (two 50 mg oral suspension of disintegrated film-coated tablets) Peposertib (Treatment C) on Day 8 under fasted condition in treatment period 2, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment B) on Day 15 under fed condition in treatment period 3. A washout period of 7 days was maintained between 3 treatment periods.
Part 1: Treatment Sequence 3: B - A - C	Experimental	Drug: PeposertibParticipants received single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment B) on Day 1 under fed condition in treatment period 1, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment A) on Day 8 under fasted condition in treatment period 2, followed by single oral dose of 100 mg (two 50 mg oral suspension of disintegrated film-coated tablets) Peposertib (Treatment C) on Day 15 under fasted condition in treatment period 3. A washout period of 7 days was maintained between 3 treatment periods.
Part 1: Treatment Sequence 4: B - C - A	Experimental	Drug: PeposertibParticipants received single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment B) on Day 1 under fed condition in treatment period 1, followed by single oral dose of 100 mg (two 50 mg oral suspension of disintegrated film-coated tablets) Peposertib (Treatment C) on Day 8 under fasted condition in treatment period 2, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment A) on Day 15 under fasted condition in treatment period 3. A washout period of 7 days was maintained between 3 treatment periods.
Part 1: Treatment Sequence 5: C - A - B	Experimental	Drug: PeposertibParticipants received single oral dose of 100 mg (two 50 mg oral suspension of disintegrated film-coated tablets) Peposertib (Treatment C) on Day 1 under fasted condition in treatment period 1, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment A) on Day 8 under fasted condition in treatment period 2, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment B) on Day 15 under fed condition in treatment period 3. A washout period of 7 days was maintained between 3 treatment periods.
Part 1: Treatment Sequence 6: C - B - A	Experimental	Drug: PeposertibParticipants received single oral dose of 100 mg (two 50 mg oral suspension of disintegrated film-coated tablets) Peposertib (Treatment C) on Day 1 under fasted condition in treatment period 1, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment B) on Day 8 under fed condition in treatment period 2, followed by single oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib (Treatment A) on Day 15 under fasted condition in treatment period 3. A washout period of 7 days was maintained between 3 treatment periods.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
Participants are nonsmoker for at least 6 months prior to Screening
Participants have a body weight greater than 50 kilogram (kg) and a body mass index within the range 18.5 to 30.0 kilogram per meter square (inclusive) at Screening
Male participants are refrain from donating sperm plus either abstain from any activity that allows for exposure to ejaculate
Female participants are not pregnant or breastfeeding

Key exclusion criteria (8 listed)

History of clinically relevant renal, cardiovascular, pulmonary disease, or endocrinology disorder at Screening
History of clinically relevant gastrointestinal disease, in particular pancreatic disease, cholecystitis, liver diseases or hepatic dysfunction at Screening
History of psychiatric or relevant neurological disorders (example, depression, epilepsy) at Screening
History of relevant skin and mucosal diseases (rash, mucositis) at Screening
Presence or history of any serious allergy (requiring hospitalization or prolonged systemic treatment) at Screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PeposertibAlso: MSC2490484A, M3814Participants received single oral dose of oral dose of 100 mg (two 50 mg film-coated tablets) Peposertib under fasting (Treatment A) or fed (Treatment B) conditions in either of 3 treatment periods.	Drug	Part 1: Treatment Sequence 1: A - B - C, Part 1: Treatment Sequence 2: A - C - B, Part 1: Treatment Sequence 3: B - A - C, Part 1: Treatment Sequence 4: B - C - A, Part 1: Treatment Sequence 5: C - A - B, Part 1: Treatment Sequence 6: C - B - A
PeposertibAlso: MSC2490484A, M3814Participants received single oral dose of 100 mg (two 50 mg oral suspension) Peposertib (Treatment C) in either of 3 treatment periods under fasted conditions.	Drug	Part 1: Treatment Sequence 1: A - B - C, Part 1: Treatment Sequence 2: A - C - B, Part 1: Treatment Sequence 3: B - A - C, Part 1: Treatment Sequence 4: B - C - A, Part 1: Treatment Sequence 5: C - A - B, Part 1: Treatment Sequence 6: C - B - A

Primary outcome

Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Sampling (AUC0-tlast) of Peposertib
Time frame: Pre-dose and 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 12.0, 24.0 and 36.0 hours after post-dose in each treatment period
Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Peposertib
Time frame: Pre-dose and 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 12.0, 24.0 and 36.0 hours after post-dose in each treatment period
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast pred/Lambda z, where Clast pred was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLOQ) and Lambda z was the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
Part 1: Maximum Observed Plasma Concentration (Cmax) of Peposertib
Time frame: Pre-dose and 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 12.0, 24.0 and 36.0 hours after post-dose in each treatment period
Cmax was obtained directly from the concentration versus time curve.

5 secondary outcomes

Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: up to Day 7 of each treatment period
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale
Time frame: up to Day 7 of each treatment period
Part 1: Number of Participants With Clinically Relevant Changes From Baseline in Laboratory Parameters
Time frame: up to Day 7 of each treatment period
Part 1: Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs
Time frame: up to Day 7 of each treatment period
Part 1: Number of Participants With Clinically Relevant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings
Time frame: up to Day 7 of each treatment period

Results and safety

Results posted to the registry on 6 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Treatment Sequence 1: A - B - C	2	2
Part 1: Treatment Sequence 2: A - C - B	2	2
Part 1: Treatment Sequence 3: B - A - C	2	2
Part 1: Treatment Sequence 4: B - C - A	2	2
Part 1: Treatment Sequence 5: C - A - B	2	2
Part 1: Treatment Sequence 6: C - B - A	2	2

Primary outcome: Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Sampling (AUC0-tlast) of Peposertib

Time frame: Pre-dose and 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 12.0, 24.0 and 36.0 hours after post-dose in each treatment period. Geometric mean (95% Confidence Interval). Unit: hour*nanogram per milliliter (h*ng/mL)

Measure	Peposertib Fed n = 11	Peposertib Oral Suspension n = 11	Peposertib Fasted n = 11
Value	1253 (840 to 1868)	1256 (856 to 1844)	1019 (683 to 1520)

Peposertib Fed vs Peposertib Fasted: Ratio of geometric least square mean (%): 123.81 (90% CI 108.04 to 141.87)
Peposertib Oral Suspension vs Peposertib Fasted: Ratio of geometric least square mean (%): 124.83 (90% CI 111.50 to 139.76)

Population analysed: The Pharmacokinetic (PK) Analysis Set was a subset of the Safety Analysis Set and included all participants who received at least 1 dose of active Peposertib and provide at least 1 measurable post-dose concentration.

Primary outcome: Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Peposertib

Measure	Peposertib Fed n = 11	Peposertib Oral Suspension n = 11	Peposertib Fasted n = 9
Value	1301 (878 to 1929)	1310 (889 to 1931)	1102 (675 to 1798)

Peposertib Fed vs Peposertib Fasted: Ratio of geometric least square mean (%): 110.28 (90% CI 100.71 to 120.77)
Peposertib Oral Suspension vs Peposertib Fasted: Ratio of geometric least square mean (%): 119.05 (90% CI 104.47 to 135.67)

Population analysed: The PK analysis set was a subset of the Safety Analysis Set and included all participants who received at least 1 dose of active Peposertib and provide at least 1 measurable post-dose concentration. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Primary outcome: Part 1: Maximum Observed Plasma Concentration (Cmax) of Peposertib

Measure	Peposertib Fed n = 11	Peposertib Oral Suspension n = 11	Peposertib Fasted n = 11
Value	279 (208 to 374)	456 (291 to 715)	265 (182 to 386)

Peposertib Fed vs Peposertib Fasted: Ratio of geometric least square mean (%): 104.47 (90% CI 79.15 to 137.90)
Peposertib Oral Suspension vs Peposertib Fasted: Ratio of geometric least square mean (%): 173.29 (90% CI 135.78 to 221.16)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Part 1: up to Day 7 of each treatment period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peposertib Fasted	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Peposertib Fed	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Peposertib Oral Suspension	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12

Limitations and caveats (from the sponsor): The Part 2 of the study was not conducted as per Sponsor's decision.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37905356Becker 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.
Trial Awareness and Transparency websiteLink provided by the sponsor.
Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
Individual participant dataSharing planned: No. IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Responsible study director

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Peposertib in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Sampling (AUC0-tlast) of Peposertib (time frame: Pre-dose and 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 12.0, 24.0 and 36.0 hours after post-dose in each treatment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04702698, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.