Overview

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

Status:
Completed
Trial end date:
2017-04-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Amplyx Pharmaceuticals
Pfizer
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.