A randomized, open-label study evaluating the effects of food and dosing regimen on Q-122 pharmacokinetics in healthy female volunteers

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001542381

Enrollment

Registered

2017-11-07

Start date

2017-11-30

Completion date

2018-01-14

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

45 Years to No maximum

Healthy volunteers

Yes

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

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.

Outcome results