Influence of Fluvoxamine on the Pharmacokinetics of BI 409306

NCT02853136 | Completed Phase 1 Results

• 2 other identifiers: 1289.352016-000752-10
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the influence of fluvoxamine on the pharmacokinetics of BI 409306

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

  This outcome measured the area under the concentration-time curve of BI 409306 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) in the main phase of the trial (10mg BI 409306 + 100 mg Fluvoxamine (T2) and 10 mg BI 409306 (R2)), as defined in the clinical trial protocol. The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.

  -2:00h (hours: minutes) before drug administration and 0:20h, 0:30h, 0:45h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.

• Maximum Measured Concentration of BI 409306 in Plasma (Cmax)

  This outcome measure presents the maximum measured concentration of BI 409306 in plasma in the main phase of the trial (10mg BI 409306 + 100 mg Fluvoxamine (T2) and 10 mg BI 409306 (R2)), as defined in the clinical trial protocol. The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.

  -2:00h (hours: minutes) before drug administration and 0:20h, 0:30h, 0:45h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.

Secondary Outcomes (1)

• Area Under the Concentration-time Curve of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)

  -2:00h (hours: minutes) before drug administration and 0:20h, 0:30h, 0:45h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.

Study Arms (4)

3 mg BI 409306 [R1]/3 mg BI 409306 + 100 mg Fluvoxamine [T1]

EXPERIMENTAL

The subjects were administered 3 milligram \[mg\] BI 409306 Powder for Oral Solution \[PfOS\] single dose for one day in the pilot phase, taken as 6 mL of 0.5 mg/mL BI 409306 solved in 5 mg/mL \[milliLiter\] tartaric acid orally with 240 mL of water after an overnight fast of at least 10h, followed by 3 mg BI 409306 PfOS single dose for one day together with 100 mg Fluvoxamine \[Fevarin®\] film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h. Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1. There was a washout of at least 3 days after administration of BI 409306 in R1.

Drug: Fluvoxamine; Drug: BI 409306 - Powder for oral solution (PfOS)

3 mg BI 409306 + 100 mg Fluvoxamine [T1]/3 mg BI 409306 [R1]

EXPERIMENTAL

The subjects were administered 3 mg BI 409306 PfOS single dose for one day in the pilot phase together with 100 mg Fluvoxamine \[Fevarin®\] film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h, followed by 3 mg BI 409306 PfOS single dose for one day orally with 240 mL of water after an overnight fast of at least 10h. Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1. There was a washout of at least 6 days after combined administration of BI 409306 and Fluvoxamine in T1.

Drug: Fluvoxamine; Drug: BI 409306 - Powder for oral solution (PfOS)

10 mg BI 409306 [R2]/10 mg BI 409306 + 100 mg Fluvoxamine [T2]

EXPERIMENTAL

The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day in the main phase orally with 240 mL of water after an overnight fast of at least 10h, followed by 10 mg BI 409306 film-coated tablet single dose for one day together with 100 mg Fluvoxamine \[Fevarin®\] film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h. Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1. There was a washout of at least 3 days after administration of BI 409306 in R2.

Drug: Fluvoxamine; Drug: BI 409306 - film coated tablet

10 mg BI 409306 + 100 mg Fluvoxamine [T2]/10 mg BI 409306 [R2]

EXPERIMENTAL

The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day in the main phase together with 100 mg Fluvoxamine \[Fevarin®\] film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h, followed by 10 mg BI 409306 single dose film-coated tablet for one day orally with 240 mL of water after an overnight fast of at least 10h. Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1. There was a washout of at least 6 days after combined administration of BI 409306 and Fluvoxamine in T2.

Drug: Fluvoxamine; Drug: BI 409306 - film coated tablet

Interventions

Fluvoxamine DRUG

Fluvoxamine

Also known as: Fevarin®

10 mg BI 409306 + 100 mg Fluvoxamine [T2]/10 mg BI 409306 [R2]; 10 mg BI 409306 [R2]/10 mg BI 409306 + 100 mg Fluvoxamine [T2]; 3 mg BI 409306 + 100 mg Fluvoxamine [T1]/3 mg BI 409306 [R1]; 3 mg BI 409306 [R1]/3 mg BI 409306 + 100 mg Fluvoxamine [T1]

BI 409306 - Powder for oral solution (PfOS) DRUG

BI 409306 - Powder for oral solution (PfOS)

3 mg BI 409306 + 100 mg Fluvoxamine [T1]/3 mg BI 409306 [R1]; 3 mg BI 409306 [R1]/3 mg BI 409306 + 100 mg Fluvoxamine [T1]

BI 409306 - film coated tablet DRUG

BI 409306 - film coated tablet

10 mg BI 409306 + 100 mg Fluvoxamine [T2]/10 mg BI 409306 [R2]; 10 mg BI 409306 [R2]/10 mg BI 409306 + 100 mg Fluvoxamine [T2]

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
• Age of 18 to 50 years (incl.)
• BMI of 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
• Male or female subjects who meet any of the following criteria starting from screening until 30 days after trial completion regarding adequate contraception:
• Non-hormonal intra-uterine device in combination with condom
• Sexually abstinent
• Surgically sterilised (including hysterectomy)
• A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
• Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 60 to 90 mmHg, or pulse rate outside the range of 50 to 85 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and 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
• Chronic or relevant acute infections
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Use of drugs within 30 days prior to administration of trial medication that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
• Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
• Current smoker or ex-smoker who quit smoking less than 30 days prior to screening
• Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)
• Drug abuse or positive drug screening

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

Fluvoxamine; Solutions; BI 409306

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals; Pharmaceutical Preparations

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 2, 2016
• Study Start: August 25, 2016
• Primary Completion: October 17, 2016
• Study Completion: October 25, 2016
• Last Updated: August 21, 2024
• Results First Posted: August 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)