Placebo-controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1271 in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02168595
• Date of registration: 17/06/2014
• Prospective Registration: No
• Primary sponsor: GlycoMimetics Incorporated
• Public title: Placebo-controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of GMI-1271 in Healthy Volunteers
• Scientific title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Intravenous Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GMI-1271 in Healthy Adult Subjects
• Date of first enrolment: June 2014
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02168595
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Barbara Cook, MD
• Affiliation: Celerion

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Healthy adult male and/or females, 19 to 60 years of age, inclusive.

2. Medically healthy with no clinically significant screening results (e.g., laboratory
profiles, medical histories, vital signs, ECGs, physical examination) as deemed by the
PI.

3. Females of childbearing potential must either be sexually inactive (abstinent) for 3
months prior to dosing or be using an acceptable birth control method

4. Females must have a negative pregnancy test at the time of screening and prior to
dosing for inclusion in the study.

5. Understands the study procedures in the informed consent form (ICF), and be willing
and able to comply with the protocol.

Exclusion Criteria:

1. Subject is mentally or legally incapacitated or has significant emotional problems at
the time of screening visit or expected during the conduct of the study.

2. History or presence of clinically significant medical or psychiatric condition or
disease in the opinion of the PI.

3. History of any illness that, in the opinion of the PI, might confound the results of
the study or poses an additional risk to the subject by their participation in the
study.

4. Hemoglobin level below the lower limit of normal at screening or check-in.

5. Any liver function test (e.g., AST, ALT, bilirubin) 1.5x the upper limit of normal at
screening or check-in.

6. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBsAg), or hepatitis C antibodies (HCV).

7. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at
screening.

8. Heart rate is lower than 40 bpm or higher than 99 bpm at screening.

9. QTc interval >430 msec for males or >450 msec for females, or history of prolonged QT
syndrome.

10. Estimated creatinine clearance < 90 ml/min at screening or check-in.

11. Blood donation or significant blood loss within 56 days prior to dosing.

12. Plasma donation within 7 days prior to dosing.

13. Participation in another clinical trial within 28 days prior to dosing. The 28-day
window will be derived from the date of the last study procedure (such as last blood
collection or dosing) in the previous study to Day 1 of Period 1 of the current study.

Note: If an increase (>1.5 x N) in bilirubin is present at screening additional liver
function tests may be performed (such as ALT, AST, ALP, albumin, and direct and indirect
bilirubin) to determine if the increase of bilirubin is due to Gilbert-Meulengracht
syndrome. If consistent with Gilbert's syndrome, the Investigator and Sponsor may decide
not to consider this as an exclusion. Any such decision will be documented in the study
record.



Age minimum: 19 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Adult Subjects

Intervention(s)

Drug: GMI-1271

Drug: Placebo

Primary Outcome(s)

Treatment related adverse events [Time Frame: Day 1-15]

Secondary Outcome(s)

Area under the plasma concentration vs time curve (AUC) [Time Frame: Day 1-3]

Pharmacodynamics [Time Frame: Day 1-3]

Peak plasma concentration (Cmax) [Time Frame: Day 1-3]

Time of peak plasma concentration (Tmax) [Time Frame: Day 1-3]

Secondary ID(s)

GMI-1271-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors