Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects
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ClinicalTrials.gov Identifier: NCT02446002 |
Recruitment Status :
Completed
First Posted : May 15, 2015
Last Update Posted : October 26, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Lofexidine + Naltrexone | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects |
Study Start Date : | May 2015 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Lofexidine + Naltrexone |
Drug: Lofexidine + Naltrexone
Lofexidine HCl (two 0.2 mg tablets) will be administered as a single oral dose (0.4 mg) on Day 1 and on Day 11.Commercially available naltrexone HCL tablets will be administered as a single oral 25 mg dose on Day 4 and as a single oral 50 mg dose on Days 5 through 13. On Day 11 administration of both naltrexone and lofexidine will occur. Dose administration times for each drug are to be standardized for all treatment days. The scheduling of the naltrexone dose is to be standardized so that the naltrexone dose is administered 2 hours after the lofexidine dose on Day 11 when both drugs are administered.
Other Names:
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- PK Profile for Lofexidine only: Cmax, Tmax, AUC, AUC 0-24, AUC 0-t, AUC 0-infinity, λz, and CL/F [ Time Frame: Day 1 through Day 11 ]Descriptive statistics will be used to summarize lofexidine concentrations at each time point and PK parameters by treatment phase.Comparisons will be made between Day 1 and Day 11 for Cmax, AUC0-24, AUC0-t, AUC0-∞, Tmax, and t1/2
- PK Profile for Naltrexone only: Cmax, AUC0-24, Tmax, and CL/F [ Time Frame: Day 4 through Day 11 ]Descriptive statistics will be used to summarize naltrexone concentrations at each time point and PK parameters by treatment phase. Comparisons will be made between Day 10 and Day 11 for Cmax, AUC0-24, and Tmax at steady-state.
- All Adverse Events (AEs) and Serious Adverse Events (SAEs) will be reported throughout the study and will include all subjects who receive at least 1 dose of study medication. [ Time Frame: Day 1 through 14 ]Treatment phases include lofexidine alone/washout [Days 1-3]; naltrexone alone [Days 4-10]; and lofexidine plus naltrexone [Days 11-14]
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- BMI between 18 and 35 kg/m^2
- females of childbearing potential must be using contraception or must be surgically sterile
- Subject is in good health based on medical history, physical exam, laboratory profile, electrocardiogram (ECG) as judged by investigator
- If subject smokes, subject agrees to limit smoking while in the study to not more than 10 cigarettes per day
- Subject provides written informed consent before participation in the study, and an appropriate HIPAA (Health Insurance Portability and Accountability Act) form is signed and dated
Exclusion Criteria:
- Subject has a history of clinically significant disease, including cardiovascular, gastrointestinal (GI), renal, hepatic, pulmonary, endocrine, hematologic, vascular, immunologic, metabolic, or collagen disease.
- Females: pregnant, breastfeeding, planning to become pregnant, or a positive pregnancy test.
- Clinically significant illness within 4 weeks before Day -1.
- Use of herbal supplements within 3 weeks before Day -1.
- Received treatment of more than a single dose of a CYP3A4 inducer (e.g., rifampin, barbiturates, phenytoin, glucocorticoids, St. John's Wort) within 4 weeks before Day -1.
- Received treatment with a strong CYP3A4 inhibitor (e.g., ketoconazole, diltiazem, macrolide antibiotics) within 2 weeks before Day -1.
- Currently taking any medication identified as potentially producing QTc prolongations of 10 msec or greater.
- Received an investigational medication during the last month (30 days) preceding Day -1.
- Consumes more than 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) or has a significant history of alcohol abuse or drug/chemical abuse within the last 1 year.
- Consumed grapefruit, grapefruit juice, Seville oranges, and/or starfruit within 4 days before Day -1.
- Positive urine drug or alcohol screen, unless positive result is due to an approved prescribed medication (e.g., pain medication or benzodiazepine).
- Positive human immunodeficiency virus (HIV) test or tests positive for hepatitis B surface antigen.
- Known allergy or intolerance to any compound in the test product or any other closely related compound.
- Donated blood/plasma, exceeding 500 mL, during the 3-month period before Day -1.
- Abnormal cardiovascular exam at Screening, including any of the following: clinically significant abnormal ECG (e.g., second or third degree heart block, uncontrolled arrhythmia, QTcF [Fridericia's correction] interval >450 msec for males and >470 msec for females); pulse<45 bpm or symptomatic bradycardia; systolic blood pressure <90 mmHg or symptomatic hypotension; blood pressure >165/95 mmHg; or prior history of myocardial infarction within 1 year before Day -1.
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): NCT02446002
United States, Texas | |
Worldwide Clinical Trials | |
San Antonio, Texas, United States, 78217 |
Principal Investigator: | George Atiee, MD | Worldwide Clinical Trials |
Responsible Party: | USWM, LLC (dba US WorldMeds) |
ClinicalTrials.gov Identifier: | NCT02446002 |
Other Study ID Numbers: |
USWM-LX1-1009 1R01DA030916 ( Other Grant/Funding Number: National Institute on Drug Abuse ) |
First Posted: | May 15, 2015 Key Record Dates |
Last Update Posted: | October 26, 2017 |
Last Verified: | October 2017 |
Volunteer |
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