First in Human Study to Investigate the Safety and Tolerability, Pharmacokinetics, Itraconazole Drug-drug-interaction and Food Effect of BAY1817080

NCT ID: NCT02817100

Last Updated: 2017-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-22
• Study Completion Date: 2017-08-23

Brief Summary

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1817080 using a placebo controlled, randomized, single center design. In addition the influence of itraconazole and food on the pharmacokinetics of BAY1817080 will be investigated.

Conditions

Clinical Trials, Phase I as Topic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

BAY1817080

Study Part 1: Dose 1 to 7 of BAY1817080 (increasing dose levels; redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food \[American breakfast\]); Study part 2: Dose 1 to 4 of BAY1817080 together with an American breakfast (increasing dose levels; redosing of BAY1817080 at dose group 1, 2 and 4 together with food \[Continental breakfast\])

Group Type: EXPERIMENTAL

BAY1817080

Intervention Type: DRUG

Study part 1: Escalating doses of BAY1817080; single dose administration; solid dosage form (redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food \[American breakfast\]) Study part 2: Escalating doses of BAY1817080; single dose administration together with an American breakfast; solid dosage form (redosing of BAY1817080 at dose group 1, 2 and 4 together with food \[Continental breakfast\])

Itraconazole

Intervention Type: DRUG

Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)

Placebo

Study Part 1: Placebo Dose 1 to 7 of BAY1817080; Study Part 2: Placebo Dose 1 to 4 of BAY1817080

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Study part 1: Escalating doses of respective placebos; single dose administration; solid dosage form (redosing of placebo at dose group 1 and 2 together with itraconazole; redosing of placebo at dose group 4 together with food \[American breakfast\]) Study part 2: Escalating doses of respective placebos; single dose administration together with an American breakfast; solid dosage form (redosing of placebo at dose group 1, 2 and together with food \[Continental breakfast\])

Itraconazole

Intervention Type: DRUG

Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)

Interventions

BAY1817080

Study part 1: Escalating doses of BAY1817080; single dose administration; solid dosage form (redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food \[American breakfast\]) Study part 2: Escalating doses of BAY1817080; single dose administration together with an American breakfast; solid dosage form (redosing of BAY1817080 at dose group 1, 2 and 4 together with food \[Continental breakfast\])

Intervention Type: DRUG

Placebo

Study part 1: Escalating doses of respective placebos; single dose administration; solid dosage form (redosing of placebo at dose group 1 and 2 together with itraconazole; redosing of placebo at dose group 4 together with food \[American breakfast\]) Study part 2: Escalating doses of respective placebos; single dose administration together with an American breakfast; solid dosage form (redosing of placebo at dose group 1, 2 and together with food \[Continental breakfast\])

Intervention Type: DRUG

Itraconazole

Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects
• Age: 18 to 45 years (inclusive)
• Body mass index (BMI) : ≥18 and ≤30 kg/m²
• Race: White

Exclusion Criteria

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Relevant diseases within the last 4 weeks prior to the first drug administration
• Existing chronic diseases requiring medication
• Known or suspected malignant tumors or carcinoma in situ (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment)
• Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
• Use of any drugs which might influence the results of the trial within 14 days prior to administration or during the trial until follow-up including drugs which might affect the pharmacokinetics

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

CRS Clinical Research Services Berlin GmbH

Berlin, , Germany

Countries

Germany

References

Reif S, Schultze-Mosgau MH, Engelen A, Piel I, Denner K, Roffel A, Tiessen R, Klein S, Francke K, Rottmann A. Mass Balance and Metabolic Pathways of Eliapixant, a P2X3 Receptor Antagonist, in Healthy Male Volunteers. Eur J Drug Metab Pharmacokinet. 2024 Jan;49(1):71-85. doi: 10.1007/s13318-023-00866-0. Epub 2023 Dec 3.

Reference Type: DERIVED

PMID: 38044419 (View on PubMed)

Other Identifiers

2016-000253-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

18183

Identifier Type: -

Identifier Source: org_study_id