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Trial record 9 of 51 for:    "Invasive Aspergillosis" | "Anti-Infective Agents"

Single Ascending Oral Dose Study of F901318

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ClinicalTrials.gov Identifier: NCT02394483
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : September 19, 2016
Sponsor:
Collaborator:
Simbec-Orion Research
Information provided by (Responsible Party):
F2G Ltd.

Brief Summary:

Double blind, placebo controlled, ascending single oral dose, sequential group study. Forty subjects will complete the study in 5 cohorts (Groups A to E), each group consisting of 8 subjects. Each subject will be on study for approximately 6 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 6 (120 hours post-dose). Each cohort will be dosed in a leading edge design in which two subjects will receive study drug (1 active and 1 placebo) on the first dosing day, and the last 6 will receive study drug (5 active and 1 placebo) on the second dosing day.

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

Cohorts will be dosed at 2 weekly intervals. There will be a review of safety data, after the first two subjects have been dosed and before dosing of the subsequent six subjects. There will be a complete review of safety and pharmacokinetic data of each cohort prior to each dose escalation.


Condition or disease Intervention/treatment Phase
Invasive Aspergillosis Drug: F901318 safety Drug: F901318 tolerability Drug: F901318 pharmacokinetics Other: Placebo safety Other: Placebo tolerability Other: Placebo pharmacokinetics Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 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, Single Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects
Study Start Date : October 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

Arm Intervention/treatment
Experimental: Cohort A active
2 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics
Drug: F901318 safety
Safety assessments
Other Name: adverse events

Drug: F901318 tolerability
Tolerability assessments
Other Name: adverse events

Drug: F901318 pharmacokinetics
Pharmacokinetic assessments
Other Name: metabolism

Placebo Comparator: Cohort A placebo
Matching placebo safety,placebo tolerability and placebo pharmacokinetics
Other: Placebo safety
Safety assessments
Other Name: adverse events

Other: Placebo tolerability
Placebo tolerability
Other Name: adverse events

Other: Placebo pharmacokinetics
Plaacebo pharmacokinetics
Other Name: metabolism

Experimental: Cohort B active
4 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics
Drug: F901318 safety
Safety assessments
Other Name: adverse events

Drug: F901318 tolerability
Tolerability assessments
Other Name: adverse events

Drug: F901318 pharmacokinetics
Pharmacokinetic assessments
Other Name: metabolism

Placebo Comparator: Cohort B placebo
Matching placebo safety,placebo tolerability and placebo pharmacokinetics
Other: Placebo safety
Safety assessments
Other Name: adverse events

Other: Placebo tolerability
Placebo tolerability
Other Name: adverse events

Other: Placebo pharmacokinetics
Plaacebo pharmacokinetics
Other Name: metabolism

Experimental: Cohort C active
6 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics
Drug: F901318 safety
Safety assessments
Other Name: adverse events

Drug: F901318 tolerability
Tolerability assessments
Other Name: adverse events

Drug: F901318 pharmacokinetics
Pharmacokinetic assessments
Other Name: metabolism

Placebo Comparator: Cohort C placebo
Matching placebo safety,placebo tolerability and placebo pharmacokinetics
Other: Placebo safety
Safety assessments
Other Name: adverse events

Other: Placebo tolerability
Placebo tolerability
Other Name: adverse events

Other: Placebo pharmacokinetics
Plaacebo pharmacokinetics
Other Name: metabolism

Experimental: Cohort D active
8 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics
Drug: F901318 safety
Safety assessments
Other Name: adverse events

Drug: F901318 tolerability
Tolerability assessments
Other Name: adverse events

Drug: F901318 pharmacokinetics
Pharmacokinetic assessments
Other Name: metabolism

Placebo Comparator: Cohort D placebo
Matching placebo safety,placebo tolerability and placebo pharmacokinetics
Other: Placebo safety
Safety assessments
Other Name: adverse events

Other: Placebo tolerability
Placebo tolerability
Other Name: adverse events

Other: Placebo pharmacokinetics
Plaacebo pharmacokinetics
Other Name: metabolism

Experimental: Cohort E active
10 mg/kg orally F901318 safety,F901318 tolerability and F901318 pharmacokinetics
Drug: F901318 safety
Safety assessments
Other Name: adverse events

Drug: F901318 tolerability
Tolerability assessments
Other Name: adverse events

Drug: F901318 pharmacokinetics
Pharmacokinetic assessments
Other Name: metabolism

Placebo Comparator: Cohort E placebo
Matching placebo safety,placebo tolerability and placebo pharmacokinetics
Other: Placebo safety
Safety assessments
Other Name: adverse events

Other: Placebo tolerability
Placebo tolerability
Other Name: adverse events

Other: Placebo pharmacokinetics
Plaacebo pharmacokinetics
Other Name: metabolism




Primary Outcome Measures :
  1. Safety (Adverse events) [ Time Frame: 10 days ]
    Adverse events


Secondary Outcome Measures :
  1. Tolerability (Adverse events) [ Time Frame: 10 days ]
    Adverse events

  2. Pharmacokinetics (Area under concentration time curve, AUC) [ Time Frame: 120 hours ]
    Area under concentration time curve

  3. Pharmacokinetics (Cmax) [ Time Frame: 12 hours ]
    Cmax



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Subjects will be males of any ethnic origin between 18 and 45 years of age and with a body weight of 60-100 kg inclusive.
  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.

Exclusion Criteria:

  1. Male subjects who are not willing to use appropriate contraception (such as a condom) during the study and until follow up.
  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) 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.
  6. Subjects who have donated any blood, plasma or platelets in the 2 months prior to screening or who have made donations on more than two occasions within the 12 months preceding the dose administration.
  7. Subjects with a significant history of drug allergy as determined by the Investigator.
  8. Subjects who have any clinically significant allergic disease (excluding non-active hay fever) as determined by the Investigator.
  9. Subjects who have a supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, confirmed by a repeat assessment.
  10. Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits).
  11. Subjects with a positive urine drug screen or alcohol breath test result at screening or first admission.
  12. Subjects must not have smoked for 3 months prior to first dose administration unless otherwise specified by the Investigator or Sponsor.
  13. Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, ocular (including minor trauma) haematological or other major disorders as determined by the Investigator.
  14. Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for HIV antibodies.
  15. Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study, such as QTcB interval >430 msec, 2nd or 3rd degree atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolff-Parkinson-White Syndrome, defined as PR<110 msec, confirmed by a repeat ECG.
  16. Subjects who, in the opinion of the Investigator, should not participate in the study for any other reason.

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): NCT02394483


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

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Responsible Party: F2G Ltd.
ClinicalTrials.gov Identifier: NCT02394483     History of Changes
Other Study ID Numbers: F901318-01-03-15
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: August 2016

Keywords provided by F2G Ltd.:
Single ascending dose
double blind

Additional relevant MeSH terms:
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Aspergillosis
Mycoses
Olorofim
Antifungal Agents
Anti-Infective Agents