Ala Wai Phase 1 safety and tolerability study with 14 healthy participants

Phase 1

Completed

• Conditions: the treatment and prophylaxis of influenza; Infection - Other infectious diseases

• Registration Number: ACTRN12616001475437
• Lead Sponsor: Clinical Network Services Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. 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.
2. Medically healthy with clinically insignificant screening results (e.g. laboratory profiles, medical history, ECGs, physical exam) as judged by the PI.
3. Negative urine drug screen /alcohol breath test prior to Day -1.
4. Availability of participant for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, Informed Consent Form.
5. 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.
6. 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.

7. 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 Criteria

1. History of confirmed chronic and/or serious pulmonary disease, including asthma or chronic obstructive pulmonary disease (COPD).
2. Known or suspected history of hypersensitivity to any components of the investigational product – zanamivir, glycerol or diglycerides.
3. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
4. Presence or history of clinically significant lung infection
5.Presence or history of influenza within the past three weeks.
6. 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.
7. Participating in a clinical trial with an investigational drug within 30 days preceding this trial.
8. Blood donation within 45 days preceding this trial.
9. 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).
10. Use of zanamivir (Relenza Registered Trademark) within 4 days preceding confinement for either dose period.
Presence or history of clinically significant lung infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Assessments: This study assesses the safety and tolerability of AWP-09VDB-S under FED and FASTING conditions. Safety will be determined by evaluating physical examinations, ECGs, vital signs, clinical laboratory parameters, and AEs. If deemed necessary, additional safety measurements will be performed at the discretion of the PI and/or Sponsor.[A follow-up safety evaluation will be performed 7(+/-2) days after each dose. This may be done at the start of Period 2 if less than 9 days has elapsed]

Secondary Outcome Measures

Name	Time	Method
To assess the pharmacokinetics (PK) of a single oral dose of AWP-09VDB-S when administered to healthy volunteers in the presence and absence of food. Pharmacokinetic profiles: Cmax, Tmax, AUClast, AUC0-inf, Kel, t1/2 and CL/F computed from plasma zanamivir concentrations and Ae(t’-t’’), Ae0-24, Re, Rmax, and TRmax computed from the individual urine zanamivir concentrations.<br>Urine PK smaples will be collected and refrigerated during the collection intervals. At the end of each interval, total urine volume will be measured, and an aliquot will be collected and stored frozen for PK analysis if deemed necessary by Ala Wai Pharma.[PK blood sample (0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8 and12 hours after dosing).<br>PK urine collection (during collection interval times of 0- 4, 4- 8, 8- 12 and 12-24 hours after dosing).]