Drug/Drug Interactions With F901318

NCT03095547 | Withdrawn Phase 1

• 1 other identifier: F901318-01-11-17
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study of interactions between F901318 and multiple doses of posaconazole and pantoprazole and single doses of cyclosporine A and tacrolimus in healthy subjects. Pharmacokinetic (PK) profiles, safety and tolerability will be assessed.

Conditions

Invasive Aspergillosis

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics: Area under curve 0-t

  Area under curve 0-t

  21 days

Secondary Outcomes (1)

• Tolerability: Adverse events

  21 days

Study Arms (4)

F901318 & cyclosporine A & tacrolimus

EXPERIMENTAL

Interaction between cyclosporine A and tacrolimus with F901318

Drug: cyclosporine A; Drug: F901318; Drug: Tacrolimus

F901318 & posaconazole

EXPERIMENTAL

Interaction between posaconazole and F901318

Drug: Posaconazole; Drug: F901318

F901318 & pantoprazole

EXPERIMENTAL

Interaction between pantoprazole and F901318

Drug: Pantoprazole; Drug: F901318

F901318

EXPERIMENTAL

F901318 alone

Drug: F901318

Interventions

cyclosporine A DRUG

Pharmacokinetic assessment Area Under the plasma concentration: time Curve (AUC) 0-t

F901318 & cyclosporine A & tacrolimus

Posaconazole DRUG

Pharmacokinetic assessment AUC 0-tau

F901318 & posaconazole

Pantoprazole DRUG

Pharmacokinetic assessment AUC 0-tau

F901318 & pantoprazole

F901318 DRUG

Pharmacokinetic assessment AUC 0-tau

F901318; F901318 & cyclosporine A & tacrolimus; F901318 & pantoprazole; F901318 & posaconazole

Tacrolimus DRUG

Pharmacokinetic assessment AUC 0-t

F901318 & cyclosporine A & tacrolimus

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 and females of any ethnic origin between 18 and 55 years of age and weighing between 60 and 100 kg inclusive.
• 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 but congenital non haemolytic hyperbilirubinaemia is acceptable.
• Negative pregnancy test in all females of child bearing potential at screening and Day -1
• 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 have not used for at least three months prior to screening and are not willing to use appropriate contraception during the study and for 3 months after end of dosing.
• Pregnancy and lactation.
• For cohort A only, clinically significant infection within the past 6 months or recurring herpes infections within the past 6 months or history of tuberculosis
• 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) 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
• Bio-Kinetic Europe, Ltd.: collaborator

MeSH Terms

Interventions

Cyclosporine; posaconazole; Pantoprazole; olorofim; Tacrolimus

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Macrolides; Lactones

Study Officials

• David Bell, MD

  BioKinetic Europe

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Three arm parallel group evaluation with fourth arm in series

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: March 29, 2017
• Study Start: May 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 1, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share