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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
Sex
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
29/11/2017
Actual
30/11/2017
Date of last participant enrolment
Anticipated
Actual
14/01/2018
Date of last data collection
Anticipated
Actual
15/02/2018
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 297873 0
Commercial sector/Industry
Name [1] 297873 0
Que Oncology
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
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
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
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
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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.