Pharmacokinetics of Metronidazole Dermal Products

NCT03271983 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: HP-00071790
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Generate human PK data by collecting data following the application of metronidazole formulations.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (1)

• PK Parameters

  Area under the concentration-time curve from 0 to 25 h

  3 study sessions/subject; each session was 25 h; blood samples obtained at the following time points: -60 min, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 23, 24, 25 h; at least one week washout period between each study session

Study Arms (3)

metronidazole gel 1

OTHER

RLD gel

Drug: Metronidazole gel 1

metronidazole gel 2

OTHER

generic gel

Drug: Metronidazole gel 2

metronidazole cream

OTHER

generic cream

Drug: Metronidazole cream

Interventions

Metronidazole gel 1 DRUG

RLD gel

Also known as: metronidazole

metronidazole gel 1

Metronidazole gel 2 DRUG

generic gel

Also known as: metronidazole

metronidazole gel 2

Metronidazole cream DRUG

generic cream

Also known as: metronidazole

metronidazole cream

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men or non-pregnant, women who are of any ethnic background between the age of 18 to 45 years old
• Subjects must be non-smokers/tobacco users (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, snuff, gum, patches or electronic cigarettes) over the previous 2 months and are not currently using tobacco products
• Provide written informed consent before initiation of any of the study procedures
• Agree not to participate in another clinical trial/study during the study period or to participate in an investigational drug study for at least 1 month after the last study session
• Able to adhere to the study protocol and study restrictions
• Able to participate in all study sessions
• Subjects have upper arms large enough to allow for placement of 200 cm2 \[31 in2\] area for applications of gel or cream. The arm distance from the greater tubercle to the olecranon process should be a minimum of 30 cm. The circumference of the upper arms should be a minimum of 30 cm.
• Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination and medication history
• Negative urine drug screening test (cannabinoids, amphetamines, barbiturates, benzodiazepine, cocaine, methadone, opiates, PCP)
• Have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine transaminase (ALT) and aspartate aminotransferase (AST)
• Have normal screening laboratories for urine protein and urine glucose
• Female subjects must be of non-childbearing potential (as defined as surgically sterile \[i.e. history of hysterectomy or tubal ligation\] or postmenopausal for more than 1 year), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of each study session, and must agree to use reliable hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner
• Agrees not to donate blood to a blood bank throughout participation in the study and for at least 3 months after last study session
• Have a normal ECG; must not have the following to be acceptable: pathologic Q wave abnormalities, significant ST-T wave changes, left ventricular hypertrophy, right bundle branch block, left bundle branch block. (sinus rhythm is between 55-100 beats per minute)
• Have normal vital signs:

You may not qualify if:

• Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or positive urine pregnancy test on the morning of the first day of any study session
• Smokers/tobacco users (current use or use over the previous 2 months of nicotine-containing substances (e.g., cigarettes, cigars, chewing tobacco, gum, snuff, patch or electronic cigarettes)
• Current participation in any ongoing investigational drug trial/study or clinical drug trial/study
• History as either reported by the subject or evident to the investigator of infectious disease or skin infection or of chronic skin disease (e.g., psoriasis, atopic dermatitis)
• History of diabetes
• History of significant skin cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and did not involve the investigative sites
• Body Mass Index (BMI) ≥30 kg/m2
• History of chronic obstructive pulmonary disease or cor pulmonale, or substantially decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression
• Active positive Hepatitis B, C and/or HIV test results
• Positive urine drug screening test
• Use of chronic prescription medications during the period 0 to 30 days; or over-the-counter medications (e.g. antihistamines, topical corticosteroids) and short term (\<30 days) prescription medications during the period 0-3 days before a study session (vitamins, herbal supplements and birth control medications not included)
• Currently taking daily anticoagulants (warfarin, heparin, rivaroxaban, dabigatran, etc…) within the past month prior to entry into the study
• History of blood dyscrasia (abnormal in structure, function and quality)
• History of Crohn's disease
• Donation or loss of greater than one pint of blood within 60 days of entry to the study

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

General Clinical Research Center (GCRC) at the University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Metronidazole

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Audra Stinchcomb
• Organization: University of Maryland, Baltimore

astinchc@rx.umaryland.edu

410-706-2646

Study Officials

• Audra L Stinchcomb, PhD

  University of Maryland, Baltimore School of Pharmacy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 5, 2017
• Study Start: April 9, 2019
• Primary Completion: October 31, 2019
• Study Completion: November 3, 2019
• Last Updated: May 17, 2022
• Results First Posted: May 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)