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

Primary Purpose

Fungal Infection

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Fungal Infection

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

PRA Health Sciences (PRA) - Early Development Services (EDS)
PRA Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Arm Label

Cohort 1a, Period A

Cohort 1a, Period B

Cohort 1a, Period C

Cohort 1a, Period D

Cohort 1b, Period E

Cohort 1b, Period F

Cohort 2

Cohort 3

Cohort 4

Arm Description

single intravenous dose, crossover

single oral dose, crossover

single oral dose

single oral dose, crossover

Single oral dose under fasted conditions, crossover

Single oral dose under fed conditions, crossover

Multiple oral doses

Multiple oral doses in presence of CYP probe substrates

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Pharmacokinetics of single and multiple doses of APX001 as measured by maximum observed concentration (Cmax).

Pharmacokinetics of single and multiple dose of APX001 as measured by area under the curve (AUC).

Pharmacokinetics of single and multiple doses of APX001 as measured by terminal half life (t1/2).

Pharmacokinetics of single and multiple doses of APX001 as measured by volume of distribution (Vd).

Pharmacokinetics of single and multiple doses of APX001 as measured by elimination rate constant (Kel).

Pharmacokinetics of single and multiple doses of APX001 as measured by accumulation ratio.

Full Information

NCT ID

NCT02957929

First Posted

November 1, 2016

Last Updated

September 23, 2022

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02957929

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

October 31, 2016 (Actual)

Primary Completion Date

April 20, 2017 (Actual)

Study Completion Date

April 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fungal Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1a, Period A

Arm Type

Experimental

Arm Description

single intravenous dose, crossover

Arm Title

Cohort 1a, Period B

Arm Type

Experimental

Arm Description

single oral dose, crossover

Arm Title

Cohort 1a, Period C

Arm Type

Experimental

Arm Description

single oral dose

Arm Title

Cohort 1a, Period D

Arm Type

Experimental

Arm Description

single oral dose, crossover

Arm Title

Cohort 1b, Period E

Arm Type

Experimental

Arm Description

Single oral dose under fasted conditions, crossover

Arm Title

Cohort 1b, Period F

Arm Type

Experimental

Arm Description

Single oral dose under fed conditions, crossover

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Multiple oral doses

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Multiple oral doses

Arm Title

Cohort 4

Arm Type

Experimental

Arm Description

Multiple oral doses in presence of CYP probe substrates

Intervention Type

Drug

Intervention Name(s)

APX001 single IV dose

Intervention Type

Drug

Intervention Name(s)

APX001 single oral dose 1

Intervention Type

Drug

Intervention Name(s)

APX001 single oral dose 2

Intervention Type

Drug

Intervention Name(s)

APX001 single oral dose 3

Intervention Type

Drug

Intervention Name(s)

APX001 single oral dose fasted

Intervention Type

Drug

Intervention Name(s)

APX001 single oral dose fed

Intervention Type

Drug

Intervention Name(s)

APX001 multiple oral doses 1

Intervention Type

Drug

Intervention Name(s)

APX001 multiple oral doses 2

Intervention Type

Drug

Intervention Name(s)

APX001 multiple oral doses 3

Intervention Type

Drug

Intervention Name(s)

Cytochrome P450 substrates

Intervention Type

Drug

Intervention Name(s)

Matching placebo control

Primary Outcome Measure Information:

Title

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Pharmacokinetics of single and multiple doses of APX001 as measured by maximum observed concentration (Cmax).

Time Frame

21 days

Title

Pharmacokinetics of single and multiple dose of APX001 as measured by area under the curve (AUC).

Time Frame

21 days

Title

Pharmacokinetics of single and multiple doses of APX001 as measured by terminal half life (t1/2).

Time Frame

21 days

Title

Pharmacokinetics of single and multiple doses of APX001 as measured by volume of distribution (Vd).

Time Frame

21 days

Title

Pharmacokinetics of single and multiple doses of APX001 as measured by elimination rate constant (Kel).

Time Frame

21 days

Title

Pharmacokinetics of single and multiple doses of APX001 as measured by accumulation ratio.

Time Frame

21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

PRA Health Sciences (PRA) - Early Development Services (EDS)

City

Groningen

ZIP/Postal Code

9728 NZ

Country

Netherlands

Facility Name

PRA Health Sciences

City

Groningen

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=APX001-102

Description

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

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