Trial Outcomes & Findings for Study of the Safety of QRH-882260 Heptapeptide (NCT NCT02574858)

Last Updated: 2018-01-02

Results Overview

Review of laboratory values for abnormalities after intervention with QRH-882260. If the first post-procedure labs are outside normal range, they must be within 20% of the subject's baseline lab values or returning towards normal range. Lab values not meeting these criteria must be repeated weekly until they peak and weekly until normal or within 20% of baseline level or within normal range.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

25 participants

Primary outcome timeframe

48 hours

Results posted on

2018-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	QRH-886620 The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining seven subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration). QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Safety of QRH-882260 Heptapeptide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	QRH-886620 n=25 Participants The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining seven subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration). QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.
Age, Customized Ages of Participants · 22-29 years	4 Participants n=5 Participants
Age, Customized Ages of Participants · 30-39 years	2 Participants n=5 Participants
Age, Customized Ages of Participants · 40-49 years	5 Participants n=5 Participants
Age, Customized Ages of Participants · 50-59 years	8 Participants n=5 Participants
Age, Customized Ages of Participants · 60-69 years	6 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 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	1 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	QRH-886620 n=25 Participants The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining 22 subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration). QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.
Number of Subjects With Abnormal Lab Values	1 Participants

PRIMARY outcome

Timeframe: 30 minutes

Review of EKG for abnormalities after intervention with QRH-882260. Paired EKGs will be reviewed for electrical changes post QRH-882260 ingestion.

Outcome measures

Outcome measures
Measure	QRH-886620 n=25 Participants The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining 22 subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration). QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.
Number of Subjects With Abnormal EKG	0 Participants

Adverse Events

QRH-886620

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	QRH-886620 n=25 participants at risk The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining 22 subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration). QRH-882260: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.
Renal and urinary disorders Elevated creatinine level	4.0% 1/25 • Number of events 1

Additional Information

Dr. D. Kim Turgeon

University of Michigan

Phone: 734-764-6860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place