Overview

Maxigesic® IV Phase 3 Exposure Study

Status:
Completed
Trial end date:
2020-07-07
Target enrollment:
0
Participant gender:
All
Summary
The study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AFT Pharmaceuticals, Ltd.
Criteria
Inclusion Criteria:

- Is male or female ≥ 18 years of age.

- Is classified by the anesthesiologist as P1 to P2 in the American Society of
Anesthesiologists (ASA) Physical Status Classification System.

- Requires multiple doses of parenterally administered nonopioid analgesics over
multiple days as a result of surgery (non-laparoscopic general, plastic or orthopedic
surgery).

- Has an expected stay in facility ≥ 48 hours.

- Has a body weight ≥ 45 kg.

- If female and of childbearing potential, is nonlactating and nonpregnant.

- If female, is either not of childbearing potential (defined as postmenopausal for at
least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy,
or hysterectomy]) or practicing 1 of the following medically acceptable methods of
birth control: i) Hormonal methods such as oral, implantable, injectable, or
transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual
menstrual cycle period) before study drug administration; ii) Total abstinence from
sexual intercourse since the last menses before study drug administration through
completion of final study visit; iii) Intrauterine device (IUD); iv) Double-barrier
method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or
cream).

- Is able to provide written informed consent to participate in the study and able to
understand the procedures and study requirements.

- Must voluntarily sign and date an informed consent form (ICF) that is approved by an
Institutional Review Board (IRB) before the conduct of any study procedure.

- Is willing and able to remain at the study site for at least 48 hours and to attend a
follow-up visit at 7 ± 2 days after the last dose of study drug.

Exclusion Criteria:

- Has a known history of allergic reaction or clinically significant intolerance to
acetaminophen, aspirin, opioids, or any nonsteroidal anti-inflammatory drugs (NSAIDs,
including ibuprofen); history of NSAID-induced bronchospasm (subjects with the triad
of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and
should be considered carefully); or hypersensitivity, allergy, or significant reaction
to sulfa (including sulfonamide) medicines, ingredients of the study drug, or any
other drugs used in the study including anesthetics and antibiotics that may be
required on the day of surgery.

- Has experienced any surgical complications or other issues that, in the opinion of the
Investigator, could compromise the safety of the subject if he or she participates in
the study or could confound the results of the study.

- Has a known or suspected history of alcoholism or drug abuse or misuse within 2 years
of screening or evidence of tolerance or physical dependence before dosing with study
drug.

- Has any clinically significant unstable cardiac, respiratory, neurological,
immunological, hematological, or renal disease or any other condition that, in the
opinion of the Investigator, could compromise the subject's welfare, ability to
communicate with the study staff, or otherwise contraindicate study participation.

- Has a history or current diagnosis of a significant psychiatric disorder that, in the
opinion of the Investigator, would affect the subject's ability to comply with the
study requirements.

- Has tested positive either on the urine drug screen or on the alcohol breathalyzer
test. Subjects who test positive and can produce a prescription for the medication
from their physician may be considered for study enrolment at the discretion of the
Investigator.

- Has a history of a clinically significant (Investigator opinion) gastrointestinal (GI)
event within 6 months before screening or has any history of peptic or gastric ulcers
or GI bleeding.

- Has a surgical or medical condition of the GI or renal system that might significantly
alter the absorption, distribution, or excretion of any drug substance.

- Is considered by the Investigator, for any reason to be an unsuitable candidate to
receive the study drug.

- Is receiving systemic chemotherapy, has an active malignancy of any type, or has been
diagnosed with cancer within 5 years before Screening (excluding treated squamous or
basal cell carcinoma of the skin).

- Is currently receiving anticoagulants (e.g. heparin or warfarin).

- Has received a course of systemic corticosteroids (either oral or parenteral) within 3
months before screening (inhaled nasal steroids and regional/limited area application
of topical corticosteroids (Investigator discretion) are allowed).

- Has a history of chronic use (defined as daily use for > 2 weeks) of NSAIDs, opiates,
or glucocorticoids (except inhaled nasal steroids and regional/limited topical
corticosteroids), for any condition within 6 months before study drug administration.
Aspirin at a daily dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the
subject has been on a stable dose regimen for ≥ 30 days before screening and has not
experienced any relevant medical problem.

- Has a significant renal or hepatic disease, as indicated by clinical laboratory
assessment (results ≥ 3 times the upper limit of normal [ULN] for any liver function
test, including aspartate aminotransferase [AST], alanine aminotransferase [ALT], or
creatinine ≥ 1.5 times the ULN).

- Has any clinically significant laboratory finding at screening that, in the opinion of
the Investigator, contraindicates study participation.

- Previously participated in another clinical study of Maxigesic® IV or received any
investigational drug or device or investigational therapy within 30 days before
Screening.