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Trial record 18 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants

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ClinicalTrials.gov Identifier: NCT03498170
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Mereo BioPharma

Brief Summary:
An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.

Condition or disease Intervention/treatment Phase
Interaction Drug: BCT197 Drug: Itraconazole 200 mg Phase 1

Detailed Description:
This will be an open label study conducted in healthy male participants at a single centre. Each participant will participate in a screening visit and 2 study periods. At the first study period, all participants will receive a single dose of BCT197 and at study period 2, all participants will receive 14 daily doses of itraconazole and a single dose of BCT197.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants
Actual Study Start Date : March 19, 2018
Actual Primary Completion Date : May 3, 2018
Actual Study Completion Date : May 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Period 1 and Period 2

Period 1 - BCT197 14mg on Day 1

Period 2 - itraconazole 200mg on Day 1 to 14 and BCT197 14mg on Day 7

Drug: BCT197
Single dose of BCT197
Other Name: Acumapimod

Drug: Itraconazole 200 mg
Single dose of itraconazole
Other Name: Sporanox




Primary Outcome Measures :
  1. Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of itraconazole. [ Time Frame: Pre-dose to Day 15 ]

    Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1.

    Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.


  2. Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of itraconazole. [ Time Frame: Pre-dose to Day 15 ]

    Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1.

    Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7.



Secondary Outcome Measures :
  1. The number of adverse events during administration of BCT197 alone and in the presence of itraconazole. [ Time Frame: Day 1 to Day 21 ]

Other Outcome Measures:
  1. Corrected QT interval of the electrocardiogram (QTc). [ Time Frame: Pre-dose to Day 15 ]
    Period 1: Pre-dose, 2, 4, 6, 8, 24 and 168 hours post BCT197 dose on Day 1. Period 2: Pre-dose, 2, 4, 6, 8, 24, 168 and 192 hours post BCT197 dose on Day 7.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male participants.
  • Non-smokers (including e-cigarettes).
  • Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
  • Willing to use highly effective barrier contraception methods.
  • Male participants must not donate sperm during the study.

Exclusion Criteria:

  • Any participants with pre-existing active skin disease.
  • Laboratory values at screening which are deemed to be clinically significant.
  • Participants with abnormal liver function tests.
  • 12 Lead ECG with QTcF >450 msec.
  • Allergy to any of BCT197 excipients.
  • Known hypersensitivity or intolerance to itraconazole.
  • Taking medications known to cause QTc prolongation.
  • Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
  • Any clinically significant illness within 30 days prior to study drug administration.
  • Participants who, in the opinion of the Investigator, are unsuitable for participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498170


Locations
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United States, Florida
inVentiv Health Clinical Research Services LLC
Miami, Florida, United States, 33136
Sponsors and Collaborators
Mereo BioPharma
Investigators
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Study Director: Jacqueline Parkin, PhD FRCP Mereo BioPharma

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Responsible Party: Mereo BioPharma
ClinicalTrials.gov Identifier: NCT03498170     History of Changes
Other Study ID Numbers: MBCT103
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mereo BioPharma:
Healthy Male Volunteers

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors