ISRCTN11913515
Completed
Phase 1
A randomized, single-blind, placebo-controlled study of the effects of repeat doses of NT-814 on oestradiol and other sex hormone concentrations in healthy pre-menopausal female volunteers
KaNDy Therapeutics0 sites33 target enrollmentSeptember 18, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Reproductive hormone levels in women with hormone-driven disorders
- Sponsor
- KaNDy Therapeutics
- Enrollment
- 33
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33624806/ (added 13/08/2021)
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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