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Trial registered on ANZCTR


Registration number
ACTRN12617001542381
Ethics application status
Approved
Date submitted
31/10/2017
Date registered
7/11/2017
Date last updated
5/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, open-label study evaluating the effects of food and dosing regimen on Q-122 pharmacokinetics in healthy female volunteers
Scientific title
A randomized, open-label study evaluating the effects of food and dosing regimen on Q-122 pharmacokinetics in healthy female volunteers
Secondary ID [1] 293244 0
Protocol Q122-1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vasomotor symptoms in breast cancer patients/survivors 305290 0
Condition category
Condition code
Metabolic and Endocrine 304595 304595 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1: single oral dose of 200mg Q-122 on Day 1 and on Day 11.
Subjects will receive one dose after a high fat meal, and the other after fasting at least 10 hours.

Part 2: 200mg Q-122 orally once daily for 10 days, or 100mg Q-122 orally twice daily for 10 days.
Subjects remain in the trial unit during the entire dosing period to ensure compliance.
Intervention code [1] 299504 0
Treatment: Drugs
Comparator / control treatment
Part 1: fed or fasted dosing
Part 2: once or twice daily dosing
Control group
Dose comparison

Outcomes
Primary outcome [1] 303821 0
Part 1: Single dose plasma PK parameters including Cmax, Tmax, t1/2, Kel, AUC0-inf, AUClast, %AUCexp, Clast, Tlast, Cl/F, and Vd/F under fed and fasted conditions.
Timepoint [1] 303821 0
PK samples collected pre dose and at 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours post dose
Primary outcome [2] 303822 0
Part 2: Repeat dose PK parameters including Cmax, Ctrough, Tmax, t1/2, Kel, AUC0-inf, AUClast, AUCtau, Cavg. Cmin, %Fluctuation
Timepoint [2] 303822 0
PK samples collected pre dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 10, 12 and 16 hrs post dose 1, pre dose on Days 2 to 10, and 24, 36, 48, 60, 72 and 96 hrs post dose 10.
Secondary outcome [1] 340222 0
Part 1 and Part 2: Safety data including adverse events, physical examination findings, vital signs, ECGs and clinical laboratory results
Timepoint [1] 340222 0
Part 1: From baseline to Day 18
Post baseline time points;
- Vitals signs pre and post dose, Days 4, 10, 14 and 18
- Physical exam Days 2, 4, 10, 12, 14 and 18
- ECG Days 10 and 18
- Lab tests Days 3, 5 10, 13, 15 and 18

Part 2: From baseline to Day 17
Post baseline time points
- Vitals signs Day 1 pre and post dose, Days 10, 13, 14 and 17
- Physical exam Days 13 and 17
- ECG Day 17
- Lab tests Days 6, 10 and 17

Eligibility
Key inclusion criteria
- Female subjects 45 years of age or older.
- generally healthy absent any clinically significant and relevant abnormality
- of non-childbearing potential.
- willing to adhere to the visit and assessment schedule, and protocol restrictions
Minimum age
45 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Clinically relevant history of hepatic, renal, pulmonary, psychiatric, or infectious disorders that would interfere with study procedures
- History of stomach banding or other surgery, Crohn’s disease, ulcerative colitis, (diabetic) gastroparesis, irritable bowel syndrome, irregular bowel habit, GI stoma, colostomy
- Pregnant or nursing
- febrile illness within 7 days of the planned first dose of study drug.
- Participation in a clinical trial with an Investigational Product within 30 days prior to Day 1.
- Current use of tobacco, or use within 3 months of screening.
- History of substance abuse or alcohol consumption exceeding 14 drinks/week.
- Clinical laboratory abnormalities:
• ALT or AST > Grade 1
• Total Bilirubin > Grade 1
• Serum Creatinine > Grade 1
• Hematology values > upper limit of normal
- Clinically significant ECG abnormalities
- Use of medications that increase gastric pH or affect gastric motility
- Body mass index > 38.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 297873 0
Commercial sector/Industry
Name [1] 297873 0
Que Oncology
Address [1] 297873 0
Level 9, 31 Queen Street
Melbourne, VIC 3000
Country [1] 297873 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Que Oncology
Address
Level 9, 31 Queen Street
Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 296919 0
None
Name [1] 296919 0
Address [1] 296919 0
Country [1] 296919 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298923 0
Bellberry Limited
Ethics committee address [1] 298923 0
129 Glen Osmond Road
Eastwood
South Australia 5063 
Ethics committee country [1] 298923 0
Australia
Date submitted for ethics approval [1] 298923 0
04/10/2017
Approval date [1] 298923 0
31/10/2017
Ethics approval number [1] 298923 0

Summary
Brief summary
Q-122 is being developed by QUE Oncology as a treatment for vasomotor symptoms (hot flashes) in female breast cancer patients/survivors. Q-122 has been studied in three Phase 1 clinical trials in cancer patients, healthy volunteers, and breast cancer survivors taking anti-estrogen therapy who were experiencing VMS. This study is designed to determine the effect of food on Q-122 pharmacokinetic (PK) parameters (Part 1) and PK parameters following a once daily or twice daily dosing regimen.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78662 0
Dr Nicholas Farinola
Address 78662 0
CMAX Clinical Research Pty Ltd
Level 5, 18a North Terrace
Adelaide SA 5000
Country 78662 0
Australia
Phone 78662 0
+61 8 7088 7900
Fax 78662 0
Email 78662 0
nicholas.farinola@sa.gov.au
Contact person for public queries
Name 78663 0
Dr Rob Crombie
Address 78663 0
QUE Oncology Pty Limited
Level 9, 31 Queen Street
Melbourne, VIC 3000
Country 78663 0
Australia
Phone 78663 0
+61 3 9657 0731
Fax 78663 0
Email 78663 0
rcrombie@queoncology.com
Contact person for scientific queries
Name 78664 0
Dr Rob Crombie
Address 78664 0
QUE Oncology Pty Limited
Level 9, 31 Queen Street
Melbourne, VIC 3000
Country 78664 0
Australia
Phone 78664 0
+61 3 9657 0731
Fax 78664 0
Email 78664 0
rcrombie@queoncology.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary