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Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects (ORALMAD)

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ClinicalTrials.gov Identifier: NCT02737371
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
SimbecRresearch Ltd.
Information provided by (Responsible Party):
F2G Ltd.

Brief Summary:

Double blind, placebo controlled, ascending multiple (10) oral dose, sequential group study. Twenty-four subjects will complete the study in 3 cohorts (Groups A to C), each group consisting of 8 subjects. Each cohort will consist of 4 male and 4 female subjects. Each subject will be dosed for 10 days and will be on study for approximately 7 weeks. Each subject will participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 15 (120 hours post the last dose). The dose will range between 2 and 10 mg/kg daily, given as either a single daily dose or as two doses divided over the 24-hour dosing period.

All subjects will return for a post-study visit 8 to 10 days after the last dose of study medication.

Cohorts will be dosed at least at 3 weekly intervals. There will be a review of the safety and pharmacokinetic data of each cohort prior to each dose escalation.


Condition or disease Intervention/treatment Phase
Invasive Aspergillosis Drug: F901318 Dose level A oral Drug: Placebo dose level A oral Drug: F901318 Dose level B oral Drug: Placebo dose level B oral Drug: F901318 Dose level C oral Drug: Placebo Dose level C oral Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: F901318 - A Phase I, Double-Blind, Placebo Controlled, Multiple Ascending Oral Dose Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female Subjects
Actual Study Start Date : May 2016
Actual Primary Completion Date : May 22, 2017
Actual Study Completion Date : May 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
Experimental: F901318 Dose level A oral
F901318 adverse events days 1-10
Drug: F901318 Dose level A oral
Adverse events days 1-10
Other Name: antifungal agent

Placebo Comparator: Placebo Dose level A oral
Placebo adverse events days 1-10
Drug: Placebo dose level A oral
Placebo adverse events days 1-10

Experimental: F901318 Dose level B oral
F901318 adverse events days 1-10
Drug: F901318 Dose level B oral
F901318 adverse events days 1-10
Other Name: antifungal agent

Placebo Comparator: Placebo Dose level B oral
Placebo adverse events days 1-10
Drug: Placebo dose level B oral
Placebo adverse events days 1-10

Experimental: F901318 Dose level C oral
F901318 adverse events days 1-10
Drug: F901318 Dose level C oral
F901318 adverse events days 1-10
Other Name: antifungal agent

Placebo Comparator: Placebo Dose level C oral
Placebo adverse events days 1-10
Drug: Placebo Dose level C oral
Placebo adverse events days 1-10




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability [ Time Frame: 10 days ]
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability


Secondary Outcome Measures :
  1. Pharmacokinetics Area under concentration/time curve [ Time Frame: 15 days ]
    Area under concentration/time curve



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects will be males or females of any ethnic origin between 18 and 45 years of age and with a body weight of 50-100 kg inclusive. Females of child bearing potential must be established on a reliable form of contraception and have a negative pregnancy test at screening.
  2. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is acceptable).
  3. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
  4. Subjects must have ophthalmology assessments within the normal limits at screening. This includes normal Meibomian gland function.

Exclusion Criteria:

  1. Male or female subjects who are not willing to use appropriate contraception during the study and until 3 months after the last dose.
  2. Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
  3. Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration (with the exception of vitamin/mineral supplements and paracetamol) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
  4. Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
  5. Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical or biological entity) in the past 3 months since the last dose.
  6. Subjects who have donated any blood, plasma or platelets in the 3 months prior to screening or who have made donations on more than two occasions within the 12 months preceding the dose administration.

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): NCT02737371


Locations
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United Kingdom
Simbec Research Ltd
Merthyr Tydfil, Glamorgan, United Kingdom, CF48 4DR
Sponsors and Collaborators
F2G Ltd.
SimbecRresearch Ltd.
Investigators
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Principal Investigator: Girish Sharma Simbec Research

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Responsible Party: F2G Ltd.
ClinicalTrials.gov Identifier: NCT02737371     History of Changes
Other Study ID Numbers: F901318-01-06-16
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aspergillosis
Mycoses
Antifungal Agents
Miconazole
Olorofim
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 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors