Evaluation of Immediate Release Tablet

NCT02808741 | Completed Phase 1

• 1 other identifier: F901318-01-07-16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Single dose comparison of liquid and solid formulation, followed by study of effect of high fat breakfast. Evaluation of multiple dose pharmacokinetics and tolerability

Conditions

Invasive Aspergillosis

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  Area Under Concentration Time Curve

  120 hours

Secondary Outcomes (1)

• Treatment emergent adverse events

  120 hours

Study Arms (4)

F901318 SDD

EXPERIMENTAL

Liquid formulation

Drug: F901318 SDD

F901318 IR

EXPERIMENTAL

Solid formulation

Drug: F901318 IR

F901318 IR Fasting

EXPERIMENTAL

Fasting solid formulation

Drug: F901318 IR Fasting

F901318 IR Fed

EXPERIMENTAL

Fed solid formulation

Drug: F901318 IR Fed

Interventions

F901318 SDD DRUG

Pharmacokinetics area under curve

F901318 SDD

F901318 IR DRUG

Pharmacokinetics area under curve

F901318 IR

F901318 IR Fasting DRUG

Pharmacokinetics area under curve

F901318 IR Fasting

F901318 IR Fed DRUG

Pharmacokinetics area under curve

F901318 IR Fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will be healthy males or females of any ethnic origin between 18 and 55 years of age and weighing between 50-100 kg (body mass index of 18.0-32.0 kg/m2 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.

You may not qualify if:

• Subjects who do not have suitable veins for multiple vene-punctures/cannulation as assessed by the investigator at screening
• Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
• 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.

Sponsors & Collaborators

• F2G Biotech GmbH: lead
• Quotient Clinical: collaborator

Study Sites (1)

Quotient Clinical

Nottingham, United Kingdom

Location

Study Design

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

Study Record Dates

• First Submitted: June 11, 2016
• First Posted: June 22, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 28, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)