Ala Wai Phase 1 safety and tolerability study with 14 healthy participants
An Healthy Volunteer, Open-Label, Cross-Over Phase I Study to Determine the Safety, Tolerability and Pharmacokinetics of a Single Oral Dose of AWP-09VDB-S under Fed and Fasted Conditions
Clinical Network Services Pty Ltd
14 participants
Oct 18, 2016
Interventional
Conditions
Summary
An Healthy Volunteer, Open-Label, Cross-Over Phase I Study to Determine the Safety, Tolerability and Pharmacokinetics of a Single Oral Dose of AWP-09VDB-S under Fed and Fasted Conditions. AWP-09VDB-S is a novel formulation of zanamivir, neuraminidase inhibitor used for the treatment and prophylaxis of influenza, and the permeability enhancers glycerol and Capmul MCM C8 presented in a gastric resistant capsule.
Eligibility
Inclusion Criteria18
- Adult male and/or female healthy volunteers with a minimum age of at least 18 years and maximum age of 65 years at the time of screening.
- Medically healthy with clinically insignificant screening results (e.g. laboratory profiles, medical history, ECGs, physical exam) as judged by the PI.
- Negative urine drug screen /alcohol breath test prior to Day -1.
- Availability of participant for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, Informed Consent Form.
- If male, agrees to be sexually abstinent or to use a condom (with the female sexual partner also to use an effective method of contraception) when engaging in sexual activity from admission through completion of the end-of study. Participants will be advised to use a condom (with the female sexual partner also to use an effective method of contraception) for 30 days following the last administration of the investigational product, and to not donate sperm during this same period of time.
- Females of childbearing potential must either be sexually inactive (abstinent) for 14 days prior to the first administration of the investigational product and remain so through 30 days following the final dosing of the investigational product, or have been using one of the following acceptable methods of birth control for the times specified:
- a. Intra-uterine device (IUD) in place for at least 3 months prior to the first administration of the investigational product.
- b. Double barrier method (e.g., condom and diaphragm) for at least 14 days prior to the first administration of investigational product.
- c. Male partner who is surgical sterile (vasectomy) at least 6 months prior to the first administration of investigational product and is the sole sexual partner for that female participant.
- d. Adequate hormonal contraception.
- Female participants who claim to be sexually inactive, but become sexually active during the course of the study must agree to use a double barrier method (e.g., condom and diaphragm) from the time of the start of sexual activity through 30 days following the final dosing.
- In addition, female participants of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 30 days following the final dosing of the investigational product.
- Females of non-childbearing potential have undergone one of the following sterilization procedures at least 6 months prior to the first investigational product administration:
- a. Sterilization (with a copy of the confirmation test) and be using a barrier method (condom or diaphragm) throughout the study;
- b. bilateral tubal ligation with a barrier method (condom or diaphragm) throughout the study;
- c. hysterectomy;
- d. bilateral oophorectomy;
- or be postmenopausal with amenorrhea for at least 1 year prior to the first administration of the investigational product and follicle stimulating hormone (FSH) serum levels. FSH serum levels less than or equal to 20 IU/L.
Exclusion Criteria13
- History of confirmed chronic and/or serious pulmonary disease, including asthma or chronic obstructive pulmonary disease (COPD).
- Known or suspected history of hypersensitivity to any components of the investigational product – zanamivir, glycerol or diglycerides.
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Presence or history of clinically significant lung infection
- Presence or history of influenza within the past three weeks.
- Participants who meet the following criteria at baseline:
- a. ALT or AST greater than or equal to 3xULN and bilirubin greater than or equal to 2xULN, or
- b. ALT greater than or equal to 5xULN.
- Participating in a clinical trial with an investigational drug within 30 days preceding this trial.
- Blood donation within 45 days preceding this trial.
- Participants who are known to have serum hepatitis or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody or have a positive result to the test for Human Immunodeficiency Virus (HIV).
- Use of zanamivir (Relenza Registered Trademark) within 4 days preceding confinement for either dose period.
- Presence or history of clinically significant lung infection
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Interventions
New formulation of zanamivir, AWP-09VDB-S, to be administered in a gastric resistant capsule. Participants will receive two doses in total. Each dose is 2 x capsules of 150mg (300mg total) in feed and fasted state. 4-13 days washout between period 1 and 2 Compliance check of the mouth and hand at administration. FED Cohort: Participants in the fed period will be dosed following a high–fat, high-calorie breakfast. These participants will be required to fast overnight for at least 10 hours until 30 minutes prior to their scheduled dosing times, when they will be given a standard high-fat, high calorie breakfast which will be entirely consumed within 30 minutes. The breakfast will consist of two eggs fried in butter, two strips of bacon, two slices of toast with butter, four ounces of hash brown potatoes (1 serving or approximately 114 gm) and 240 mL of whole milk. Participants will fast for at least 4 hours following dosing. IP will be administered with 240 mil of water. No food is allowed for at least 4 hours post-dose. Water can be consumed as desired except for one hour after drug administration. FASTED Cohort Participants : Following an overnight fast of at least 10 hours, participants will be administered IP with 240 mL of water. No food is allowed for at least 4 hours post-dose. Water can be consumed as desired except for one hour before and after drug administration.
Locations(1)
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ACTRN12616001475437