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

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02817100
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Clinical Trials, Phase I as Topic	Drug: BAY1817080; Drug: Placebo; Drug: Itraconazole	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses (10 - 1500 mg, Tablets) of BAY1817080 Including the Effect of Food and Itraconazole on the Relative Bioavailability of BAY1817080 in Healthy Men
• Actual Study Start Date: Jul 22, 2016
• Actual Primary Completion Date: May 11, 2017
• Actual Study Completion Date: Aug 23, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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])	Drug: 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]); Drug: Itraconazole; Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)
Placebo Comparator: Placebo Study Part 1: Placebo Dose 1 to 7 of BAY1817080; Study Part 2: Placebo Dose 1 to 4 of BAY1817080	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]); Drug: Itraconazole; Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)

Outcome Measures

Primary Outcome Measures

1. Frequency of treatment-emergent adverse events [Up to 4 months]

2. Severity of treatment-emergent adverse events [Up to 4 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRS Clinical Research Services Berlin GmbH	Berlin		Germany	13353

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02817100
• Other Study ID Numbers: 18183; 2016-000253-12
• First Posted: Jun 29, 2016
• Last Update Posted: Sep 6, 2017
• Last Verified: Sep 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Itraconazole

Study Results

No Results Posted as of Sep 6, 2017