A Study in Healthy People to Test Whether Iclepertin Has an Effect on Cardiac Safety

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06070597
• Collaborator: (none)
• Enrollment: 56
• Arms: 3
• Anticipated Duration (Months): 2.6

Study Details

Study Description

Brief 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. using the method of Fridericia or Bazett interval and other ECG parameters.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Iclepertin; Drug: Iclepertin Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: A double-blind, randomised, placebo-controlled, multiple-dose, parallel group with nested crossover design trial, with moxifloxacin as positive controlA double-blind, randomised, placebo-controlled, multiple-dose, parallel group with nested crossover design trial, with moxifloxacin as positive control
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Anticipated Study Start Date: Oct 5, 2023
• Anticipated Primary Completion Date: Dec 22, 2023
• Anticipated Study Completion Date: Dec 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: Iclepertin treatment+ Placebo to Moxifloxacin Placebo to moxifloxacin (Day 1) + Iclepertin (Day 1-12) + Placebo to moxifloxacin (Day 13	Drug: Iclepertin; Iclepertin; Drug: Moxifloxacin Placebo; Placebo Moxifloxacin
Experimental: Arm B1: Iclepertin Placebo treatment + Moxifloxacin Moxifloxacin (Day 1) + Placebo to iclepertin (Day 1-12) + Placebo to moxifloxacin (Day 13) - Arm B1	Drug: Iclepertin Placebo; Placebo to Iclepertin; Drug: Moxifloxacin; Moxifloxacin; Drug: Moxifloxacin Placebo; Placebo Moxifloxacin
Experimental: Arm B2: Iclepertin Placebo treatment + Placebo to Moxifloxacin Placebo to moxifloxacin (Day 1) + Placebo to iclepertin (Day 1-12) + Moxifloxacin (Day 13) - Arm B2	Drug: Iclepertin Placebo; Placebo to Iclepertin; Drug: Moxifloxacin; Moxifloxacin; Drug: Moxifloxacin Placebo; Placebo Moxifloxacin

Outcome Measures

Primary Outcome Measures

1. QTcF change from baseline matched to the plasma concentration of iclepertin collected at the same time point [Up to 12 days]

   QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF).

Secondary Outcome Measures

1. QTcF change from baseline matched to the plasma concentration of moxifloxacin collected at the same time point [Up to 1 day]

   QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. 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

2. Age of 18 to 50 years (inclusive)

3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)

4. 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

5. 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

• 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.

Exclusion Criteria:

Subjects will not be allowed to participate, if any of the following general criteria apply:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator

2. 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

3. 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)

4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator

5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

8. History of relevant orthostatic hypotension, fainting spells, or blackouts

Further exclusion criteria apply

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT06070597
• Other Study ID Numbers: 1346-0051; 2023-504693-38-00
• First Posted: Oct 6, 2023
• Last Update Posted: Oct 6, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of Oct 6, 2023