Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957929
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Amplyx Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Fungal Infection Drug: APX001 single IV dose Drug: APX001 single oral dose 1 Drug: APX001 single oral dose 2 Drug: APX001 single oral dose 3 Drug: APX001 single oral dose fasted Drug: APX001 single oral dose fed Drug: APX001 multiple oral doses 1 Drug: APX001 multiple oral doses 2 Drug: APX001 multiple oral doses 3 Drug: Cytochrome P450 substrates Drug: Matching placebo control Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : October 2016
Actual Primary Completion Date : April 20, 2017
Actual Study Completion Date : April 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Cohort 1a, Period A
single intravenous dose, crossover
Drug: APX001 single IV dose
Drug: Matching placebo control
Experimental: Cohort 1a, Period B
single oral dose, crossover
Drug: APX001 single oral dose 1
Drug: Matching placebo control
Experimental: Cohort 1a, Period C
single oral dose
Drug: APX001 single oral dose 2
Drug: Matching placebo control
Experimental: Cohort 1a, Period D
single oral dose, crossover
Drug: APX001 single oral dose 3
Drug: Matching placebo control
Experimental: Cohort 1b, Period E
Single oral dose under fasted conditions, crossover
Drug: APX001 single oral dose fasted
Drug: Matching placebo control
Experimental: Cohort 1b, Period F
Single oral dose under fed conditions, crossover
Drug: APX001 single oral dose fed
Drug: Matching placebo control
Experimental: Cohort 2
Multiple oral doses
Drug: APX001 multiple oral doses 1
Drug: Matching placebo control
Experimental: Cohort 3
Multiple oral doses
Drug: APX001 multiple oral doses 2
Drug: Matching placebo control
Experimental: Cohort 4
Multiple oral doses in presence of CYP probe substrates
Drug: APX001 single IV dose
Drug: APX001 multiple oral doses 3
Drug: Cytochrome P450 substrates



Primary Outcome Measures :
  1. 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). [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Pharmacokinetics of single and multiple doses of APX001 as measured by maximum observed concentration (Cmax). [ Time Frame: 21 days ]
  2. Pharmacokinetics of single and multiple dose of APX001 as measured by area under the curve (AUC). [ Time Frame: 21 days ]
  3. Pharmacokinetics of single and multiple doses of APX001 as measured by terminal half life (t1/2). [ Time Frame: 21 days ]
  4. Pharmacokinetics of single and multiple doses of APX001 as measured by volume of distribution (Vd). [ Time Frame: 21 days ]
  5. Pharmacokinetics of single and multiple doses of APX001 as measured by elimination rate constant (Kel). [ Time Frame: 21 days ]
  6. Pharmacokinetics of single and multiple doses of APX001 as measured by accumulation ratio. [ Time Frame: 21 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957929


Locations
Layout table for location information
Netherlands
PRA Health Sciences
Groningen, Netherlands
Sponsors and Collaborators
Amplyx Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Michael R Hodges, MD Amplyx Pharmaceuticals

Layout table for additonal information
Responsible Party: Amplyx Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02957929     History of Changes
Other Study ID Numbers: APX001-102
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Mycoses