A First in Human study in ascending doses of FDY-5301.

Phase 1

Completed

• Conditions: acute myocardial infarction; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12616001165471
• Lead Sponsor: Clinical Network Services Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1)Aged between 18 and 65 years (inclusive).
2)Subjects must be infertile or agree to the use of medically reliable contraceptive methods (i.e. double barrier) for the duration of the study and for 30 days after study completion.
3)Body Mass Index (BMI) 18-30 inclusive.
4)Euthyroid confirmed by thyroid function testing at screening.
5)Adequate venous access for venipuncture and cannulation for drug administration.
6)Fluent in the English language.
7)A creatinine clearance of greater than 75 mL/min
8)In good general health as determined by medical screening.
9)Ability to provide informed consent

Exclusion Criteria

1)Any chronic illness requiring prescription medication.
2)Presence or history of any thyroid disorder or presence of goiter upon examination
3)History of and/or hypersensitivity reaction to iodide or iodide containing drugs
4)Participation in any investigational study within 30 days of Visit 1.
5)Have donated blood (usually 550 mL) within 30 days of study participation
6)The need to take any over-the-counter (OTC) medications or herbal/vitamin supplements for one week prior to the check-in visit, and during the study
7)The need to take any prescription medications for two weeks prior to the check-in visit, and during the study excluding oral contraceptives, or contraceptive implants.
8)Subjects who are unable to abstain from smoking during study confinement.
9)Females not using medically reliable contraceptive methods (i.e. double barrier) or those who are nursing or pregnant
10)Use of food and/or beverages that contain caffeine or other xanthines (e.g. coffee, tea, cola and chocolate) during the 24 hours prior to dose administration and whilst confined at the clinical facility.
11)Regular drinkers of more than four (4) units of alcohol daily or those who have consumed alcohol within 24 hours pre-dose and until study completion.
12)Acute illness requiring treatment within 30 days of study entry.
13)Any history of clinically significant chronic illness including heart failure, renal failure, or liver disease
14)Have a predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs.
15)Have a history of abnormal bleeding tendencies.
16)History of Hepatitis B, Hepatitis C, acute or chronic hepatitis, or history/demonstration of Human Immunodeficiency Virus (HIV) antibodies or AIDS
17)Current history of alcohol or drug abuse (licit or illicit); or positive urine drug and alcohol screen at screening and pre-dose
18)Have blood pressure readings (after resting for 5 minutes) outside a systolic blood pressure range of 90-140 mmHg or a diastolic blood pressure outside a range of 40-90 on two consecutive measurements
19)Have any evidence of organ dysfunction, or any deviation in clinical laboratory values which is confirmed on re-examination to be clinically significant (i.e. in the opinion of the investigator would jeopardize the safety of the subject or impact the validity of the study results).
20)Inability to provide informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified