Trial Outcomes & Findings for Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression (NCT NCT01698333)

Last Updated: 2018-10-24

Results Overview

HPA axis response to stimulation by cosyntropin, dichotomized to "normal" and "abnormal". Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Day 15

Results posted on

2018-10-24

Participant Flow

Recruitment period: April 2012 to March 2013 The location of clinical sites included private dermatology clinics and clinical research centers.

All subjects who met the entry criteria were enrolled into the study.

Participant milestones

Participant milestones
Measure	122-0551 122-0551: Applied twice daily for 2 weeks
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	122-0551 n=25 Participants 122-0551: Applied twice daily for 2 weeks
Age, Continuous	50.7 years STANDARD_DEVIATION 11.64 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	21 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Islander	1 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15

Population: Analysis shown is based on the ITT population, defined as all enrolled participants who applied at least one dose of the test article and returned for at least one post-Baseline visit.

Outcome measures

Outcome measures
Measure	122-0551 n=25 Participants 122-0551: Applied twice daily for 2 weeks
Hypothalamic-Pituitary-Adrenal (HPA) Axis Response Normal	19 Participants
Hypothalamic-Pituitary-Adrenal (HPA) Axis Response Abnormal	6 Participants

Adverse Events

122-0551

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	122-0551 n=25 participants at risk 122-0551: Applied twice daily for 2 weeks
Infections and infestations Pharyngitis	4.0% 1/25 • Number of events 1 • AEs were collected from study screening (performed 20 days or more prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once. Each subject counted once for each AE Term.
Infections and infestations Upper Respiratory Infection	4.0% 1/25 • Number of events 1 • AEs were collected from study screening (performed 20 days or more prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once. Each subject counted once for each AE Term.
Injury, poisoning and procedural complications Procedural Nausea	4.0% 1/25 • Number of events 1 • AEs were collected from study screening (performed 20 days or more prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once. Each subject counted once for each AE Term.
Investigations ACTH Stimulation Test Abnormal	24.0% 6/25 • Number of events 6 • AEs were collected from study screening (performed 20 days or more prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once. Each subject counted once for each AE Term.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	4.0% 1/25 • Number of events 1 • AEs were collected from study screening (performed 20 days or more prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once. Each subject counted once for each AE Term.

Additional Information

Clinical Research

Therapeutics Inc.

Phone: 858-571-1800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 30 days prior to public dissemination. The PI may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER