Effects of Dietary Conditions on Drug Response

IRB00231935

This non-treatment study will examine how different dietary conditions may affect a person's response to commonly used drugs.

2020-09-18

2023-02-02

2023-02-02

Terminated

Early phase I

2

Inclusion Criteria: * Age 18-45 years * Fluent in written and spoken English and is capable of understanding and complying with the protocol * Medically healthy * Non-smoker * Appropriate dietary/over-the-counter/prescription/illicit drug use history * Body Mass Index between 18.5 and 34.9 * Appropriate use of birth control in females e.g., barrier methods, hormonal contraceptives, Intra Uterine Devices (IUDs) Exclusion Criteria: * Known hypersensitivity to administered drugs * Current neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary or metabolic disease for which administration of the study drugs would be contraindicated * Current psychiatric or substance use condition that would interfere with study participation * Diastolic blood pressure \>90 mmHg or a systolic pressure of \>140 mmHg * Use of medications that would interfere with study participation * Unwilling or unable to comply with the protocol * Any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage the subjects according to the protocol * Females: Pregnancy, breastfeeding, or plans to become pregnant

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a within-subjects design. Participants are not assigned to different groups/arms. This study involves administration of drug conditions in different dose sequence orders. All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be different across participants. Participants will be randomly assigned to one of several different dose sequences. As part of instructions during the informed consent process, volunteers will be given a list of drugs volunteers may receive rather than informing volunteers only of the specific drugs being administered. More drugs are listed than will be administered to increase the degree to which volunteers are "blind" to the drugs being studied. Researchers will be blind to the drug conditions on any given session because a pharmacy member with no participant interaction will assign the randomized dose sequence and prepare the study drugs.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Please note: This is a double-blind study. The investigators indicated "None (Open Label)" above because this clinical trials website form does not allow masking in a single arm study. As part of instructions during the informed consent process, volunteers will be given a list of drugs volunteers may receive rather than informing volunteers only of the specific drugs being administered. More drugs are listed than will be administered to increase the degree to which volunteers are "blind" to the drugs being studied. Researchers will be blind to the drug conditions on any given session because a pharmacy member with no participant interaction will assign the randomized dose sequence and prepare the study drugs. Masking: Triple (Participant, Investigator, Outcomes Assessor)'}}, 'enrollmentInfo': {'count': 2, 'type': 'ACTUAL'}}

2023-02-06