Multiple Ascending Oral Dose Study of F901318 in Healthy Subjects

NCT02737371 | Completed Phase 1

• 1 other identifier: F901318-01-06-16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Aspergillosis

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability

  Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability

  10 days

Secondary Outcomes (1)

• Pharmacokinetics Area under concentration/time curve

  15 days

Study Arms (6)

F901318 Dose level A oral

EXPERIMENTAL

F901318 adverse events days 1-10

Drug: F901318 Dose level A oral

Placebo Dose level A oral

PLACEBO COMPARATOR

Placebo adverse events days 1-10

Drug: Placebo dose level A oral

F901318 Dose level B oral

EXPERIMENTAL

F901318 adverse events days 1-10

Drug: F901318 Dose level B oral

Placebo Dose level B oral

PLACEBO COMPARATOR

Placebo adverse events days 1-10

Drug: Placebo dose level B oral

F901318 Dose level C oral

EXPERIMENTAL

F901318 adverse events days 1-10

Drug: F901318 Dose level C oral

Placebo Dose level C oral

PLACEBO COMPARATOR

Placebo adverse events days 1-10

Drug: Placebo Dose level C oral

Interventions

F901318 Dose level A oral DRUG

Adverse events days 1-10

Also known as: antifungal agent

F901318 Dose level A oral

Placebo dose level A oral DRUG

Placebo adverse events days 1-10

Placebo Dose level A oral

F901318 Dose level B oral DRUG

F901318 adverse events days 1-10

Also known as: antifungal agent

F901318 Dose level B oral

Placebo dose level B oral DRUG

Placebo adverse events days 1-10

Placebo Dose level B oral

F901318 Dose level C oral DRUG

F901318 adverse events days 1-10

Also known as: antifungal agent

F901318 Dose level C oral

Placebo Dose level C oral DRUG

Placebo adverse events days 1-10

Placebo Dose level C oral

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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).
• Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
• Subjects must have ophthalmology assessments within the normal limits at screening. This includes normal Meibomian gland function.

You may not qualify if:

• Male or female subjects who are not willing to use appropriate contraception during the study and until 3 months after the last dose.
• 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.
• 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.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• F2G Biotech GmbH: lead
• SimbecRresearch Ltd.: collaborator

Study Sites (1)

Simbec Research Ltd

Merthyr Tydfil, Glamorgan, CF48 4DR, United Kingdom

Location

MeSH Terms

Interventions

Antifungal Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Girish Sharma

  Simbec Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 13, 2016
• Study Start: May 1, 2016
• Primary Completion: May 22, 2017
• Study Completion: May 22, 2017
• Last Updated: May 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)