Pharmacokinetics of IV Formulation

NCT03076905 | Withdrawn Phase 1

• 2 other identifiers: F901318-01-10-17QCL117986
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Open label evaluation of a single intravenous dose of F901318 to healthy male and female subjects with pharmacokinetic and safety and tolerability evaluation.

Conditions

Invasive Aspergillosis

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile (AUC0-t)

  AUC0-t

  120 hours

Secondary Outcomes (1)

• Tolerability (Adverse events)

  120 hours

Study Arms (1)

IV drug

EXPERIMENTAL

AUC0-t of single intravenous dose of F901318

Drug: F901318

Interventions

F901318 DRUG

Evaluation of AUC0-t

IV drug

Eligibility Criteria

• Age: 18 Years - 55 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 55 years or age and weighing between 50 and 100kg.
• Females of child bearing potential must be established on a reliable form of contraception and have a negative pregnancy test at screening and Day -1
• Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (hepatic transaminases must be within normal limits, 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:

• Female and male subjects who are not, or whose partners are not willing to use appropriate contraception with two reliable forms of contraception or who are not otherwise unable to conceive children (hysterectomy, oophorectomy, tubal ligation or post menopausal).
• 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

Sponsors & Collaborators

• F2G Biotech GmbH: lead
• Quotient Clinical: collaborator

MeSH Terms

Interventions

olorofim

Study Officials

• Litza McKenzie, MD

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Assessment of IV pharmacokinetics

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 10, 2017
• Study Start: May 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 1, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share