HealthyPhase 1NCT06070597
A Study in Healthy People to Test Whether Iclepertin Has an Effect on Cardiac Safety
A Phase 1 study testing Iclepertin and Moxifloxacin in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
This study aims to evaluate the effects of iclepertin in the range of therapeutic to supra-therapeutic exposures on the (QT/QTc): Electrocardiogram (ECG) time interval from the start of the QRS complex (ECG time interval) to the end of the T wave / QT interval corrected for heart rate, e.g. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Iclepertin and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jan 2024to 5 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, ital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests without clinically significant abnormalities
- Age of 18 to 50 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Either male subject, or female subject who meets any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:
- Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal, subdermal or transdermal), plus condom
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- Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
- Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
- Sexually abstinent
- A vasectomized sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant
- Surgically sterilized (including hysterectomy)
- Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L (or the reference range from the local safety laboratory) is confirmatory), hormone replacement therapy is not permitted Note: Male subjects are not required to use contraception.
Who cannot join
- Subjects will not be allowed to participate, if any of the following general criteria apply:
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (Alanine transaminase (ALT), Aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the Upper limit of normal (ULN)
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
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- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Further exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Iclepertin on the QT Interval Following Oral Administration in Healthy Male and Female Subjects (a Double-blind, Randomised, Placebo-controlled, Multiple-dose, Parallel Group With Nested Crossover Design Trial, With Moxifloxacin as Positive Control)
This study aims to evaluate the effects of iclepertin in the range of therapeutic to supra-therapeutic exposures on the (QT/QTc): Electrocardiogram (ECG) time interval from the start of the QRS complex (ECG time interval) to the end of the T wave / QT interval corrected for heart rate, e.g. using the method of Fridericia or Bazett interval and other ECG parameters.
- Conditions
- Healthy
- Being tested
- Iclepertin, Iclepertin Placebo, Moxifloxacin, Moxifloxacin Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IclepertinDrug
Iclepertin
Iclepertin PlaceboDrug
Placebo to Iclepertin
MoxifloxacinDrug
Moxifloxacin
Moxifloxacin PlaceboDrug
Placebo Moxifloxacin
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Iclepertin treatment+ Placebo to Moxifloxacin | Experimental | Placebo to moxifloxacin (Day 1) + Iclepertin (Day 1-12) + Placebo to moxifloxacin (Day 13 Receives: Drug: Iclepertin; Drug: Moxifloxacin Placebo |
| Arm B1: Iclepertin Placebo treatment + Moxifloxacin | Experimental | Moxifloxacin (Day 1) + Placebo to iclepertin (Day 1-12) + Placebo to moxifloxacin (Day 13) - Arm B1 Receives: Drug: Iclepertin Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo |
| Arm B2: Iclepertin Placebo treatment + Placebo to Moxifloxacin | Experimental | Placebo to moxifloxacin (Day 1) + Placebo to iclepertin (Day 1-12) + Moxifloxacin (Day 13) - Arm B2 Receives: Drug: Iclepertin Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTcF change from baseline matched to the plasma concentration of iclepertin collected at the same time point
QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF).
Measured: Up to 12 days
Secondary outcomes (1)
QTcF change from baseline matched to the plasma concentration of moxifloxacin collected at the same time point
QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF).
Measured: Up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start25 Jan 2024
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A double-blind, randomised, placebo-controlled, multiple-dose, parallel group with nested crossover design trial, with moxifloxacin as positive control
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070597
- Sponsor's protocol ID
- 1346-0051
- Other IDs
- 2023-504693-38-00, 2023
- Status last verified
- Jul 2024
- First submitted
- 2 Oct 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Iclepertin on the QT Interval Following Oral Administration in Healthy Male and Female Subjects (a Double-blind, Randomised, Placebo-controlled, Multiple-dose, Parallel Group With Nested Crossover Design Trial, With Moxifloxacin as Positive Control)
- ClinicalTrials.gov ID
- NCT06070597
- Acronym / sponsor ID
- 1346-0051
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effects of iclepertin in the range of therapeutic to supra-therapeutic exposures on the (QT/QTc): Electrocardiogram (ECG) time interval from the start of the QRS complex (ECG time interval) to the end of the T wave / QT interval corrected for heart rate, e.g. using the method of Fridericia or Bazett interval and other ECG parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A double-blind, randomised, placebo-controlled, multiple-dose, parallel group with nested crossover design trial, with moxifloxacin as positive control
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Iclepertin treatment+ Placebo to Moxifloxacin | Experimental | Drug: Iclepertin, Drug: Moxifloxacin PlaceboPlacebo to moxifloxacin (Day 1) + Iclepertin (Day 1-12) + Placebo to moxifloxacin (Day 13 |
| Arm B1: Iclepertin Placebo treatment + Moxifloxacin | Experimental | Drug: Iclepertin Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin PlaceboMoxifloxacin (Day 1) + Placebo to iclepertin (Day 1-12) + Placebo to moxifloxacin (Day 13) - Arm B1 |
| Arm B2: Iclepertin Placebo treatment + Placebo to Moxifloxacin | Experimental | Drug: Iclepertin Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin PlaceboPlacebo to moxifloxacin (Day 1) + Placebo to iclepertin (Day 1-12) + Moxifloxacin (Day 13) - Arm B2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, ital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests without clinically significant abnormalities
- Age of 18 to 50 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Either male subject, or female subject who meets any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:
Key exclusion criteria (10 listed)
- Subjects will not be allowed to participate, if any of the following general criteria apply:
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (Alanine transaminase (ALT), Aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the Upper limit of normal (ULN)
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
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 |
|---|---|---|
| IclepertinIclepertin | Drug | Arm 1: Iclepertin treatment+ Placebo to Moxifloxacin |
| Iclepertin PlaceboPlacebo to Iclepertin | Drug | Arm B1: Iclepertin Placebo treatment + Moxifloxacin, Arm B2: Iclepertin Placebo treatment + Placebo to Moxifloxacin |
| MoxifloxacinMoxifloxacin | Drug | Arm B1: Iclepertin Placebo treatment + Moxifloxacin, Arm B2: Iclepertin Placebo treatment + Placebo to Moxifloxacin |
| Moxifloxacin PlaceboPlacebo Moxifloxacin | Drug | Arm 1: Iclepertin treatment+ Placebo to Moxifloxacin, Arm B1: Iclepertin Placebo treatment + Moxifloxacin, Arm B2: Iclepertin Placebo treatment + Placebo to Moxifloxacin |
Primary outcome
QTcF change from baseline matched to the plasma concentration of iclepertin collected at the same time point
Time frame: Up to 12 days
QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF).
1 secondary outcome
QTcF change from baseline matched to the plasma concentration of moxifloxacin collected at the same time point
Time frame: Up to 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Iclepertin and Moxifloxacin in people with Healthy, run by Boehringer Ingelheim 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 12 inclusion and 10 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 9 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
QTcF change from baseline matched to the plasma concentration of iclepertin collected at the same time point (time frame: Up to 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2024.