Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally

Fungal Infection Clinical Trial

Official title:

A Phase 1, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of APX001, to Investigate the Effect of Food on APX001 and to Investigate the Drug-Drug Interaction Potential of APX001

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957929
• Other study ID #: APX001-102
• Secondary ID: C4791002
• Status: Completed
• Phase: Phase 1
• Start date: October 31, 2016
• Est. completion date: April 20, 2017

Study information

• Verified date: May 2024
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase l double-blind, placebo-controlled, randomized study to investigate the safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of APX001 administered intravenously and orally, followed by an evaluation of the safety, tolerability, pharmacokinetics and drug-drug interaction potential of multiple doses of APX001 administered orally.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 20, 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Women of childbearing potential must agree to avoid pregnancy during the study and to use contraception at least 2 weeks before the start of the study until 3 months after the last dose of study drug.

• Males with partner(s) of childbearing potential must agree to use appropriate barrier contraception from the screening period until 3 months after the last dose of study drug.

• Screening hematology, clinical chemistry, coagulation and urinalysis consistent with overall good health.

• No significantly abnormal findings on physical examination, ECG and vital signs.

• Willing and able to provide written informed consent.

Exclusion Criteria:

• Any uncontrolled or active major systemic disease including, but not limited to:

cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential.

• History or presence of malignancy within the past year. Subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.

• Use of prescription medication within 14 days prior to the first dose of study drug and throughout the study.

• Use of non-prescription or over-the-counter medications within 7 days prior to the first dose of study drug and throughout the study.

• Positive results on any of the following Screening laboratory tests: serum pregnancy test, urine alcohol test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses

Intervention

Drug:
• APX001 single IV dose

• APX001 single oral dose 1

• APX001 single oral dose 2

• APX001 single oral dose 3

• APX001 single oral dose fasted

• APX001 single oral dose fed

• APX001 multiple oral doses 1

• APX001 multiple oral doses 2

• APX001 multiple oral doses 3

• Cytochrome P450 substrates

• Matching placebo control

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen
Netherlands	PRA Health Sciences (PRA) - Early Development Services (EDS)	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of single and multiple oral doses of APX001 as measured by adverse events (AEs), physical examinations (PE), vital signs (VS), laboratory safety tests, urinalysis and 12-lead electrocardiograms (ECG).		21 days
Secondary	Pharmacokinetics of single and multiple doses of APX001 as measured by maximum observed concentration (Cmax).		21 days
Secondary	Pharmacokinetics of single and multiple dose of APX001 as measured by area under the curve (AUC).		21 days
Secondary	Pharmacokinetics of single and multiple doses of APX001 as measured by terminal half life (t1/2).		21 days
Secondary	Pharmacokinetics of single and multiple doses of APX001 as measured by volume of distribution (Vd).		21 days
Secondary	Pharmacokinetics of single and multiple doses of APX001 as measured by elimination rate constant (Kel).		21 days
Secondary	Pharmacokinetics of single and multiple doses of APX001 as measured by accumulation ratio.		21 days