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Evaluation of the Pharmacokinetics and Safety of NT-814 in Post-Menopausal Women With Vasomotor Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02865538
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Nerre Therapeutics Ltd.

Brief Summary:
This is a multi-center, double-blind, randomized, placebo-controlled multiple ascending dose study in post-menopausal women with vasomotor symptoms. Single ascending doses of NT-814 will be investigated in 4 cohorts. Each cohort will comprise of 20 subjects. Subjects will be dosed for 14 days.

Condition or disease Intervention/treatment Phase
Post-menopausal Vasomotor Symptoms Drug: NT-814 Drug: Placebo (for NT-814) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Pharmacokinetics and Safety of NT-814 in Post-Menopausal Women With Vasomotor Symptoms
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : March 28, 2017
Actual Study Completion Date : March 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Placebo Comparator: NT-814 Placebo
Placebo to match NT-814 capsules administered orally, daily, for 14 days. Number of placebo capsules to match active dose.
Drug: Placebo (for NT-814)
Experimental: NT-814 50mg
NT-814 50mg to be administered as oral capsules, daily, for 14 days.
Drug: NT-814
Experimental: NT-814 100mg
NT-814 100mg to be administered as oral capsules, daily, for 14 days.
Drug: NT-814
Experimental: NT-814 150mg
NT-814 150mg to be administered as oral capsules, daily, for 14 days.
Drug: NT-814
Experimental: NT-814 200mg
NT-814 200mg to be administered as oral capsules, daily, for 14 days.
Drug: NT-814



Primary Outcome Measures :
  1. Change from baseline in physical exam, 12-lead ECGs, clinical laboratory assessments, vital signs; and adverse events (safety parameters) [ Time Frame: Day 14 ]
  2. Pharmacokinetics: Area under the curve (AUC) [ Time Frame: Days 1, 7 and 14 ]
  3. Pharmacokinetics: Maximum plasma concentration (Cmax) [ Time Frame: Days 1, 7 and 14 ]
  4. Pharmacokinetics: Time to maximum plasma concentration (Tmax) [ Time Frame: Days 1, 7 and 14 ]
  5. Pharmacokinetics: Half-life (t½) [ Time Frame: Days 1, 7 and 14 ]

Secondary Outcome Measures :
  1. Change from baseline in frequency of moderate to severe hot flashes as measured using a paper diary [ Time Frame: Days 7 and 14 ]
  2. Change from baseline in hot flash average severity as measured using a paper diary [ Time Frame: Days 7 and 14 ]
  3. Change from baseline in hot flash severity score as measured using a paper diary [ Time Frame: Days 7 and 14 ]
  4. Change from baseline in night time awakenings secondary to hot flashes as measured using a paper diary [ Time Frame: Days 7 and 14 ]
  5. Change from baseline in Luteinizing Hormone AUC 0-8 hours [ Time Frame: Day 7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Post-menopausal female subjects experiencing frequent moderate to severe hot flashes. Menopause will be defined as:

  • 12 months of spontaneous amenorrhea;
  • OR at least 6 weeks' post-surgical bilateral oophorectomy with or without hysterectomy.

Key Exclusion Criteria:

  • BMI > 35kg/m2.
  • Any active comorbid disease, ECG or laboratory result deemed by the investigator to be clinically significant and which could impact safety during study conduct or that could interfere with the study evaluation, procedures or completion.
  • Use of prohibited medications defined in the protocol.
  • Inability or unwillingness to comply with study procedures or requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865538


Locations
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United States, Florida
Avail Clinical Research
DeLand, Florida, United States, 32720
QPS/MRA (Miami Clinical Research)
Miami, Florida, United States, 33143
United States, Texas
ICON Clinical Research Unit
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Nerre Therapeutics Ltd.
Investigators
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Study Director: Chief Medical Officer Nerre Therapeutics Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nerre Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT02865538    
Other Study ID Numbers: RELENT-1
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nerre Therapeutics Ltd.:
Hot flashes
Post-menopausal