Genetic Determinants of ACEI Prodrug Activation
Nyckelord
Abstrakt
Datum
Senast verifierad: | 05/31/2020 |
Först skickat: | 02/08/2017 |
Beräknad anmälan inlämnad: | 02/08/2017 |
Först publicerad: | 02/12/2017 |
Senaste uppdatering skickad: | 06/16/2020 |
Senaste uppdatering publicerad: | 06/18/2020 |
Faktiskt startdatum för studien: | 03/31/2017 |
Uppskattat primärt slutdatum: | 12/31/2020 |
Beräknat slutfört datum: | 12/31/2020 |
Tillstånd eller sjukdom
Intervention / behandling
Drug: Enalapril
Fas
Armgrupper
Ärm | Intervention / behandling |
---|---|
Active Comparator: non-carrier control group Subjects who do not carry the CES1 variant G143E (rs71647871) will receive 10 mg Enalapril orally once daily for 7 consecutive days. | |
Active Comparator: G143E carriers group Subjects who carry the CES1 variant G143E (rs71647871) will receive 10 mg Enalapril orally once daily for 7 consecutive days. |
Urvalskriterier
Åldrar berättigade till studier | 18 Years Till 18 Years |
Kön som är berättigade till studier | All |
Accepterar friska volontärer | Ja |
Kriterier | Inclusion Criteria: - Subjects must be male and female (50:50) between the ages of 18-55 years - Females must have a negative urine pregnancy test prior to the study - All subjects must have no clinically significant diseases or clinically significant abnormal laboratory values as assessed during the screening medical history, nursing assessment, and laboratory evaluations - Informed consent must be signed by the eligible subject prior to the initiation of any study procedures Exclusion Criteria: - The presence of a known medical condition that would preclude the use of enalapril - The presence of any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion. - A positive urine pregnancy test in the MCRU prior to the study - No subjects weighing under 50 kg will be selected - The lack of use of acceptable methods of birth control unless abstinent - Subjects who regularly take medications, vitamins, herbal supplements - The use of any illicit drugs or habitual consumption of large quantities of ethanol (>3 drinks/day) - The consumption of grapefruit or grapefruit juice a week prior to, and during the study - Asians will not be included in the study as the CES1 SNP G143E is absent in this population - Subjects hypersensitive to enalapril - Subject with a history of angioedema - Smokers |
Resultat
Primära resultatåtgärder
1. The measurements of the mean area under the curve (AUC) of enalaprilat plasma concentrations [72 hours]
Sekundära resultatåtgärder
1. The measurements of the maximum enalaprilat plasma concentrations [72 hours]
2. The measurements of angiotensin converting enzyme (ACE) activity in plasma [72 hours]
3. The measurements of blood pressures (BPs) following enalapril treatment [72 hours]