Trial Outcomes & Findings for Pharmacokinetics of Metronidazole Dermal Products (NCT NCT03271983)

NCT ID: NCT03271983

Last Updated: 2022-05-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 7 participants
• Primary outcome timeframe: 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
• Results posted on: 2022-05-17

Participant Flow

Participant milestones

Measure	Topical Metronidazole Study session 1: metronidazole gel (RLD); followed by at least a one week washout period. Study session 2: metronidazole gel (generic); followed by at least a one week washout period. Study session 3: metronidazole cream (generic)
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics of Metronidazole Dermal Products

Baseline characteristics by cohort

Measure	Topical Metronidazole n=7 Participants Study session 1: metronidazole gel (RLD); followed by at least a one week washout period. Study session 2: metronidazole gel (generic); followed by at least a one week washout period. Study session 3: metronidazole cream (generic)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants
Body Mass Index (BMI)	27.5 kg/m^2 STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Measure	Study Session 1 (RLD Gel) n=7 Participants Metronidazole gel: RLD gel	Study Session 2 (Generic Gel) n=7 Participants Metronidazole gel: generic gel	Study Session 3 (Generic Cream) n=7 Participants Metronidazole cream: generic cream
PK Parameters	283 ng*h/mL Interval 118.0 to 677.0	341 ng*h/mL Interval 226.0 to 515.0	189 ng*h/mL Interval 81.3 to 441.0

Adverse Events

Study Session 1 (RLD Gel)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Study Session 2 (Generic Gel)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Study Session 3 (Generic Cream)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Study Session 1 (RLD Gel) n=7 participants at risk Metronidazole gel: RLD gel	Study Session 2 (Generic Gel) n=7 participants at risk Metronidazole gel: generic gel	Study Session 3 (Generic Cream) n=7 participants at risk Metronidazole cream: generic cream
Skin and subcutaneous tissue disorders PRURITUS	14.3% 1/7 • Number of events 1 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.	0.00% 0/7 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.	14.3% 1/7 • Number of events 1 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.
Skin and subcutaneous tissue disorders ERYTHEMA (skin reddening)	14.3% 1/7 • Number of events 1 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.	0.00% 0/7 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.	0.00% 0/7 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.
Skin and subcutaneous tissue disorders Pain at IV site	0.00% 0/7 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.	0.00% 0/7 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.	14.3% 1/7 • Number of events 1 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.
Cardiac disorders Decreased blood pressure	14.3% 1/7 • Number of events 1 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.	28.6% 2/7 • Number of events 2 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.	14.3% 1/7 • Number of events 1 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.
Cardiac disorders Decreased heart rate	14.3% 1/7 • Number of events 1 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.	0.00% 0/7 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.	0.00% 0/7 • For 25 h after product administration plus 72 h after product removal from the arms. Subjects received a phone call within 72 h after completion of the study session to determine there were no adverse events. A total of ~97 h for each study session.

Additional Information

Dr. Audra Stinchcomb

University of Maryland, Baltimore

Phone: 410-706-2646

Email: astinchc@rx.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER