Safety, tolerability and pharmacokinetics of extended release formulations of ATN-249 in healthy volunteers when dosed once a day or over several days
- Conditions
- Hereditary AngioedemaInflammatory and Immune System - Normal development and function of the immune systemHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersCardiovascular - Other cardiovascular diseasesSkin - Other skin conditions
- Registration Number
- ACTRN12618001417279
- Lead Sponsor
- ifeSci Pharmaceuticals, inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- Male
- Target Recruitment
- 6
1. Male healthy volunteers, age 18 to 55 years, inclusive;
2. Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study drug;
3. Participants must have a Body Mass Index (BMI) between 18.0 and 30.0 kg/m2 inclusive;
4. Participants must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate;
5. Participants must be a non-smoker, and must not have used any tobacco products within two months prior to screening;
6. Participant must have no contraindications to consume standard meals provided;
7. Participants who have not been sterilized must make a commitment to ensure that their partners (if of child bearing potential) use highly effective contraception during the period from dosing to 7 days post-dose (acceptable forms of contraception are oral, injected or implanted hormonal methods, or placement of an intrauterine device or intrauterine system, or abstinence); in addition to these measures, male participants should use a condom for sexual intercourse during this period. This requirement does not apply to participants in same sex relationships;
8. Participants must have the ability and willingness to attend the necessary visits to the study center;
9. Written informed consent signed prior to entry into the study.
1. Prior or ongoing medical condition, medical history, physical findings, or laboratory abnormality that, in the Investigator’s (or delegate’s) opinion, could adversely affect the safety of the participant.
2. Previous exposure to ATN-249.
3. Mentally or legally incapacitated, has significant emotional problems at the time of screening visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years. Note: Participants who have had situational depression may be enrolled in the study at the discretion of the Investigator or delegate.
4. Fever (body temperature greater than 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening.
5. History of severe allergic or anaphylactic reactions.
6. Resting blood pressure greater than 140/90 mm Hg, resting heart rate greater than 90 beats per minute or resting heart rate lower than 50 beats per minute at screening or at Day -1 (repeat measurements are allowed at the discretion of the Investigator. The resting heart rate measurement may be repeated only once if below 50 beats per minute).
7. Alkaline phosphatase (ALP), aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than 1.5 x upper limit of normal at screening. Repeat testing at screening is acceptable for out of range values following approval by the Investigator or delegate.
8. Serum potassium lower than 3.7 mmol/L or greater than 5.5 mmol/L at Screening or Day -1. Repeat testing at screening is acceptable for out of range values following approval by the Investigator or delegate.
9. Positive test for hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus (HIV) antibody at screening.
10. Participants with a positive toxicology screening panel (urine test including qualitative identification of barbiturates, Tetrahydrocannabinol (THC), amphetamines, benzodiazepines, opiates and cocaine), cotinine test or alcohol breath test.
11. Participants with a history of substance abuse or dependency or history of recreational intravenous (IV) drug use over the last 5 years (by self-declaration).
12. Regular alcohol consumption defined as greater than 21 alcohol units per week (where 1 unit equal to 284 mL of beer, 25 mL of 40% spirit or a 125 mL glass of wine). Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU until completion of the final follow-up visit.
13. Participant has left ventricular hypertrophy defined as the combination of the following ECG criteria (both #a and #b must be met):
13.a. Voltage criteria (both criteria must be met):
13.a.1 S in V1 plus R in V5 or V6 (whichever is larger) greater or equal than 35 mm; and
13.a.2 R in aVL greater or equal than 11 mm
13.b. Repolarization abnormalities (at least one criteria needs to be met):
13.b.1 At least 1mm ST depression (horizontal or down-sloping); or
13.b.2 Abnormal T wave inversions
14. Participant has other significant ECG abnormalities that might interfere with ECG analysis including evidence of a previous myocardial infarction (MI), flat T waves (particularly in the inferior leads) or more than minor non- specific ST-T wave changes or:
14.a. QRS greater than 110 milliseconds (msec),
14.b. QT interval corrected using Fridericia’s formula (QTcF) greater than 440 msec,
14.c. PR interval greater than 220 msec
14.d. Heart rate lower than 50 beats per min
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method