Reproductive hormone levels in women with hormone-driven disorders Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a Phase 1, randomized, single-blind, placebo-controlled study designed to determine the effects of NT-814 (40, 80, 120, 160 mg once daily) on GnRH pathway hormones in healthy female subjects.
Sponsors
KaNDy Therapeutics
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy, female, aged 18 to 45 years inclusive (age at time of informed consent) 2. Have regular (approximately) monthly menstrual periods 3. Be able and willing to understand and comply with the requirements of the study and give written informed consent 4. Have a body mass index (BMI) in the range 18.0 to 32.0 kg/m2 and body weight not less than 40.0 kg 5. Be judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings 6. Not be pregnant and not lactating, with no intention of pregnancy during study treatment 7. Agree to use two acceptable methods of birth control, one of which a barrier method with spermicide for the duration of participation in the study and 30 days after the last dose of study medication
Exclusion criteria
Exclusion criteria: 1. Been previously enrolled in this study or any other study with NT-814 2. Have clinically significant findings on physical examination at screening 3. Have any relevant medical history, in particular: liver or renal insufficiency, cholecystectomy, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other condition that the Investigator considers should exclude the subject 4. Undergone bilateral oophorectomy and/or hysterectomy 5. Have positive serology for any of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) 6. Have any serum biochemistry and full blood count outside the normal reference ranges and considered by the Investigator to be of clinical significance, assessed at screening and on Cycle 1 Day 21/22. Haemoglobin must not be less than 11.0 g/dL at either screening or Day 21/22 7. Have Stage 2 or higher hypertension (supine/semi-recumbent systolic blood pressure [SBP] >160 mmHg; diastolic blood pressure [DBP] >100 mmHg or Stage 1 hypertension (supine/semi-recumbent SBP 140 160 mmHg; DBP 90 100 mmHg associated with indication for treatment i.e. evidence of end-organ damage, diabetes or a 10 year cardiovascular risk, estimated using a standard calculator, e.g. https://qrisk.org/three/, greater than 20%. Measurements are based on the mean of duplicate values recorded at least 2 minutes apart and are assessed at screening, on Cycle 1 Day 21 or 22 and pre-dose on Cycle 2 Day 1 or 2 8. Have clinically relevant abnormal 12 lead ECG, including QTcF >450 msec, QRS interval >120 msec, PR interval >220 msec, assessed at screening, on Cycle 1 Day 21 or 22 and pre-dose on Cycle 2 Day 1 or 2; if any value are out of range, two repeated assessments are permitted at that time point and the value based on the mean of the triplicate measure 9. Have a history of any grade of drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders 5 criteria (or later edition if applicable) within 6 months before Screening or have a positive test result(s) for drugs of abuse (opiates including methadone, cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, and benzodiazepines) at screening, Cycle 1 Day 21 or 22, or Cycle 2 Day 1 or 2 10. Have a clinically significant acute illness within 7 days before first study drug administration 11. Been drinking, on average, more than 6 cups of coffee or other caffeinated beverages daily (where each cup of coffee or beverage contained approximately 120 mg caffeine) 12. Been smoking more than an average of 5 cigarettes (or equivalent) per day 13. Use any non-permitted prior prescription, over-the-counter or herbal medication 14. Have a history of clinically significant drug and/or food allergies, particularly known allergy to any of the excipients used in the study medications 15. Receive an investigational drug (including vaccines) or use an investigational medical device within 3 calendar months before the first dose of study medication or currently enrolled in an investigational study 16. Have major surgery within 2 calendar months before first dose of study medication,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GnRH pathway hormones measured using serum LH, FSH, oestradiol and progesterone concentrations on Days 3/4, 9/10, 15/16 and 21/22 in both Cycle 1 (baseline) and Cycle 2 (treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The safety of NT 814 measured using clinical laboratory assessments (haematology and biochemistry), vital signs (BP and HR), and recording of treatment-emergent adverse events on Days 3/4, 9/10, 15/16 and 21/22 in both Cycle 1 (baseline) and Cycle 2 (treatment) 2. The PK-PD relationship of NT-814 measured using NT-814 plasma concentration levels during Cycle 2 Days 3/4, 9/10, 15/16 and 21/22 3. Menstrual cycle length measured using the difference in cycle length (in days) between Cycle 1 and Cycle 2 | — |
Countries
United States of America
Contacts
Public ContactSteve Pawsey
Outcome results
None listed