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Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin

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ClinicalTrials.gov Identifier: NCT02348424
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal pharmacokinetics of a single 1000mg oral dose of solithromycin. Study Objectives: The primary objective is to determine the pharmacokinetics of solithromycin in plasma, vaginal, cervical, seminal, rectal, and pharyngeal fluid samples after a single 1000mg oral dose.

Condition or disease Intervention/treatment Phase
Gonorrhoea Drug: Solithromycin Phase 1

Detailed Description:
This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal pharmacokinetics of a single 1000mg oral dose of solithromycin. A total of 28 subjects (14 male, 14 female) will be enrolled and will receive a single 1000mg dose of solithromycin after a 12 hour overnight fast (water permitted). Solithromycin is a fluoroketolide antibiotic under investigation for oral and parenteral use and will be administered orally. The study duration is approximately 18 months. Study Objectives: The primary objective is to determine the pharmacokinetics of solithromycin in plasma, vaginal, cervical, seminal, rectal, and pharyngeal fluid samples after a single 1000mg oral dose. The secondary objective is to determine the safety and tolerability of a single 1000 mg oral dose of solithromycin in healthy adult subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Open Label Trial of the Safety, Tolerability, and Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin
Actual Study Start Date : May 5, 2015
Actual Primary Completion Date : January 13, 2017
Actual Study Completion Date : January 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gonorrhea

Arm Intervention/treatment
Experimental: Female solithromycin
14 females will receive a single 1000mg dose of solithromycin after a 12 hour overnight fast (water permitted) administered orally.
Drug: Solithromycin
Cohorts 1 and 2 will receive a single 1000mg dose of solithromycin after a 12 hour overnight fast (water permitted). Solithromycin is a fluoroketolide antibiotic under investigation for oral and parenteral use and will be administered orally.

Experimental: Male solithromycin
14 males will receive a single 1000mg dose of solithromycin after a 12 hour overnight fast (water permitted) administered orally.
Drug: Solithromycin
Cohorts 1 and 2 will receive a single 1000mg dose of solithromycin after a 12 hour overnight fast (water permitted). Solithromycin is a fluoroketolide antibiotic under investigation for oral and parenteral use and will be administered orally.




Primary Outcome Measures :
  1. The pharmacokinetics of solithromycin will be assessed by measurement of solithromycin levels in plasma, vaginal, cervical, seminal, rectal, and pharyngeal fluid samples at multiple time points after drug administration. [ Time Frame: Day 1 to Day 3 ]

Secondary Outcome Measures :
  1. The safety and tolerability of a single 1000mg oral dose of solithromycin will be assessed by comparing ECGs to baseline ECGs [ Time Frame: Day 1 to Day 7 ]
  2. The safety and tolerability of a single 1000mg oral dose of solithromycin will be assessed by laboratory analysis. [ Time Frame: Day 1 to Day 7 ]
  3. The safety and tolerability of a single 1000mg oral dose of solithromycin will be assessed by reported adverse effects [ Time Frame: Day 1 to Day 7 ]
  4. The safety and tolerability of a single 1000mg oral dose of solithromycin will be assessed by rotine vital signs [ Time Frame: Day 1 to Day 7 ]
  5. The safety and tolerability of a single 1000mg oral dose of solithromycin will be assessed by routine physical exams [ Time Frame: Day 1 to Day 7 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy male and non-pregnant female subjects between 18 and 45 years of age (inclusive) -Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive) -Female sexually active subjects of must use one of the following acceptable birth control methods beginning 30 days prior to dosing and through 7 days post-dose: * Abstinence * Surgical sterilization * Hormonal contraceptives other than those inserted into the vagina (e.g. NuvaRing, intrauterine devices) -Male sexually active subjects must use one of the following acceptable birth control methods from 7 days prior to dosing through 7 days after dosing: * Abstinence * Surgical sterilization -Male subjects must agree not to donate sperm for 30 days after the solithromycin dose -Willingness and ability to provide written informed consent -Willingness and ability to adhere to the lifestyle guideline restrictions outlined in the protocol -Willingness and ability to participate in all study visits as required by the protocol, including optional overnight stays or returning to the unit on Days 1, 2, and 3.

Exclusion Criteria:

-Evidence or history of clinically significant disease or current infection. --oncologic, pulmonary, hepatic, gastrointestinal, cardiovascular, hematologic, metabolic, neurologic, immunologic, nephrologic, endocrine, or psychiatric disease -History of systemic (oral or parenteral) antibiotic use within two weeks prior to administration of study drug -Any condition possibly affecting drug absorption (e.g. status post gastrectomy) -History of post-antibiotic colitis within three months prior to screening -ECG with QTc > 450msec as corrected by the Fridericia formula for both males and females, or abnormal, clinically significant finding as reported by the overreading board certified cardiologist -Blood pressure readings >140 mmHg (systolic) or >90 mm/Hg (diastolic) -Participation in another research study or receipt of an investigational agent within 30 days of administration of the study drug * Investigational agent may include vaccine, drug, biologic, device, blood product, or medication. -Use of spermicide, an intrauterine device (IUD), diaphragm, and/or vaginally inserted hormonal contraceptive (e.g. NuvaRing) seven days prior to dosing -Treatment with any CYP3A4 enzyme altering drugs, except hormonal contraceptives or topical medications, within 14 days prior to treatment with study drug: --Use of systemic prescription drugs, vitamins, or herbal supplements, which in the opinion of the investigator may interfere with solithromycin metabolism via CYP3A4, within 14 days prior to administration of the study drug including, but not limited to * Concomitant use of drugs known to prolong the QT interval including class 1a (quinidine, procainamide) or Class III (amiodarone, sotalol), or antiarrythmics * Concomitant use of drugs, food, or herbal products known to be moderate to potent inhibitors of CYP3A4 isozymes: oral antifungal agents (e.g. ketoconazole, itraconazole, posaconazole, fluconazole and voriconazole); human immunodeficiency virus (HIV) protease inhibitors (e.g. ritonavir and saquinavir), hepatitis C virus (HCV) protease inhibitors (e.g. boceprevir and telaprevir), nefazodone, fluvoxamine, conivaptan, diltiazem, verapamil, aprepitant, ticlopidine, crizotinib, imatinib; grapefruit or grapefruit juice. * Any use within the prior 7 days of drugs or herbal products known to be moderate to potent inducers of CYP3A4 isozymes: St. John's Wort, rifampin, rifabutin, anti-convulsants (e.g. phenobarbital, carbamazepine, phenytoin, rufinamide), modafinil, armodafinil, etraverine, efavirenz, bosentan. * Required current use of drugs with narrow therapeutic indices that are principally metabolized by CYP3A4 or transported by P-glycoprotein (Pgp), for which a drug interaction with solithromycin could result in higher and possibly unsafe exposures to these drugs: e.g. the P-gp substrates digoxin or colchicine and the CYP3A4 substrates alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, midazolam, pimozide, quinidine, sirolimus, tacrolimus, everolimus, and terfenadine. * Use of any non-prescription medications, vitamins, or dietary supplements , unless prior approval is granted by the investigator * Consumption of Seville oranges or products containing Seville orange components, grapefruit, or grapefruit juice within 14 days of administration of the study drug -Positive serum pregnancy test or breast feeding during the study -Positive test for human immunodeficiency virus (HIV-1), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibodies -Positive urine drug screen at Screening or Enrollment (Day -1) (marijuana, cocaine metabolite, amphetamines, opiates, phencyc lidine, methadone, barbiturates, and/or benzodiazepines) -Positive breathalyzer test for alcohol -Positive STI screen * GC, CT, syphilis, or trichomoniasis, symptomatic bacterial vaginosis (assessed by Amsel criteria), or vaginal discharge consistent with candidiasis (assessed by potassium hydroxide wet preparation) -History of clinically significant intolerance or hypersensitivity to macrolide antibiotics (as determined by the investigator) or any of the excipients in the solithromycin capsules. * Clinically significant intolerance is defined as severe nausea or vomiting after a standard dose. Note that mild nausea is common after macrolide administration and a prior history would not be a contraindication. * Likelihood of requiring treatment during the study with drugs not permitted by the protocol -Blood donation or other significant blood loss (as determined by the Investigator) within 56 days of screening -Plasma donation within seven days of screening -Laboratory values outside the eligibility ranges in the protocol (See protocol page 23 and Appendix C) for serum. -Laboratory values outside the eligibility ranges in the protocol (See protocol page 23 and Appendix C) for urinalysis. -Uncontrolled intercurrent illness (i.e. active infection) or fever (oral temperature >/=100.4 degrees Fahrenheit or >/= 38 degrees Celsius). -Known or suspected significant underlying illness including but not limited to, clinically significant liver disease, diabetes mellitus, or kidney impairment.


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): NCT02348424


Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center - Infectious Diseases
Baltimore, Maryland, United States, 21224-2735
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02348424     History of Changes
Other Study ID Numbers: 13-0069
HHSN272201500007I
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: April 5, 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
genitourinary
Neisseriaceae
pharyngeal
Solithromycin
Additional relevant MeSH terms:
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Gonorrhea
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Solithromycin
Anti-Bacterial Agents
Anti-Infective Agents