Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)
Ключови думи
Резюме
Дати
Последна проверка: | 02/28/2007 |
Първо изпратено: | 03/15/2007 |
Очаквано записване подадено: | 03/15/2007 |
Първо публикувано: | 03/19/2007 |
Изпратена последна актуализация: | 03/15/2007 |
Последна актуализация публикувана: | 03/19/2007 |
Действителна начална дата на проучването: | 05/31/2006 |
Състояние или заболяване
Интервенция / лечение
Drug: oleoyl-estrone (MP 101)
Фаза
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | All |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: - Be a male or female between the ages of 18 and 65 years, inclusive - Female subjects must be either surgically sterile or at least 2 years postmenopausal - Have a BMI of 27 - 38.9, inclusive - Have a stable weight for the past 30 days per subject report - Be otherwise healthy and have an acceptable medical history - Have negative urinalysis test results for drugs of abuse and alcohol - Have the ability to understand the requirements of the study, have provided written informed consent and agree to abide by the study restrictions - Exhibit stable behavior patterns with regard to smoking and exercise - Subject who has at least one factor of the metabolic syndrome Exclusion Criteria: - Be pregnant or nursing - Have taken exclusionary medication in the past 30 days - Have any clinically significant abnormal laboratory test as determined by the investigator - Have a clinically significant illness during the 30 days before enrollment - Have a history of testing positive for Hepatitis B virus, Hepatitis C virus, or HIV - Have a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer - Have a previous diagnosis of diabetes - Be otherwise unsuitable for the study, in the opinion of the investigator - Have an allergy to safflower seeds or its byproducts (e.g., safflower oil) - Have any postmenopausal bleeding within the last 6 months - Have been involved in a formal or informal (self-imposed) diet regimen within the last 30 days - Currently working night shifts - Have a history of known multiple miscarriages |
Резултат
Първични изходни мерки
1. To evaluate the safety and tolerability [undefined]
Вторични изходни мерки
1. To evaluate the preliminary efficacy [undefined]