Status:
COMPLETED
A Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 in Healthy Volunteers
Lead Sponsor:
Spero Therapeutics
Collaborating Sponsors:
Simbec Research
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) following single and multiple ascending dose administration of SPR720 administered orally in healthy volunte...
Detailed Description
This is a single-center, phase I, randomized, double-blind, placebo-controlled, first-in-man study. Up to 120 healthy volunteers may be enrolled in this 2-part, multi-cohort study. In both Part 1 and ...
Eligibility Criteria
Inclusion
- KEY INCLUSION CRITERIA:
- Healthy adult male or female of non-childbearing potential,18 to 55 or ≥ 65 years of age (inclusive) at the time of screening;
- Body mass index (BMI) ≥ 18.5 and ≤ 32 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive). BMI = body weight (kg) / \[height (m)\]2 (subjects 18 to 55 years of age); Body mass index (BMI) ≥ 18 and ≤ 32 (kg/m2) and weight between 50.0 and 100.0 kg (inclusive). BMI = body weight (kg) / \[height (m)\]2 (subjects 65 years of age and older);
- Medically healthy without clinically significant (CS) abnormalities as assessed by the Principal Investigator (or deputy) based on the following at screening assessments:
- a. Detailed medical history, complete physical examination, vital signs, 12-lead ECG, hematology, blood chemistry and urinalysis laboratory variables;
- Willing and able to provide written informed consent;
- Willing and able to comply with all study assessments and adhere to the protocol schedule;
- If female, must be non-lactating and be of non-childbearing potential;
- If male, must agree to not donate sperm for 90 days after the last dose of study drug and, if engaging in vaginal sexual intercourse with a female partner of childbearing potential, agree to use a condom with spermicide in addition to requesting the female partner use a highly effective method of birth control (e.g. intrauterine device, diaphragm with spermicide, hormonal contraceptives) throughout the duration of the study and for 90 days after the last dose of study drug. This criterion also applies to males who have had a vasectomy.
- KEY EXCLUSION CRITERIA:
- History or presence of any clinically significant disease state in any body system, as assessed by the Principal Investigator (or deputy), that may affect the outcome of the study or compromise the safety of the subject;
- Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the Principal Investigator (or deputy) at screening;
- Subjects who are unable to demonstrate the ability to swallow a "dummy" capsule (i.e., an empty gelatin capsule) of the size proposed for administration in a particular cohort/dose level;
- History of any clinically significant acute illness or surgery within the previous three months;
- History of chronic gastritis, gastrointestinal tract disorders, including Clostridium difficile infection; chronic liver or biliary disease;
- History of seizure disorder, except for febrile seizures in childhood;
- Documented history of significant hypersensitivity reaction or anaphylaxis to any medication;
- History of significant allergic disease requiring treatment; allergic rhinitis (hay fever) is allowed unless it has required medication for treatment or prophylaxis within the 14 days prior to randomization;
- Clinically significant screening ECG findings as assessed by the investigator;
- Subject or family history of cardiac arrhythmia, prolonged QT syndrome, Torsades de pointes, unexplained sudden cardiac arrest or syncope, sick sinus syndrome or other clinically relevant cardiac disease;
- Clinically significant abnormalities in vital signs at screening and/or prior to randomization;
- Clinically significant screening laboratory abnormalities;
- History or suspicion of routine or chronic drug or alcohol abuse or dependence within 1 year prior to randomization, and/or positive urine drug testing at screening or check-in (Day -1);
- Reported consumption of alcoholic beverages \> 21 units per week on average (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits); positive alcohol urine test at check in (Day -1);
- Use of tobacco, nicotine, or nicotine replacement products within 30 days prior to randomization or planned use during the study; positive carbon monoxide breath test at check in (Day -1);
- Use of any prescription or non-prescription medication, including herbal products, vitamins and vaccines within 7 days (or 5 half-lives whichever is longer) prior to randomization or planned use during the study period;
- Consumption of grapefruit or grapefruit-containing products in the 7 days prior to randomization;
- Donation of more than 500 mL of blood or plasma within 30 days prior to randomization, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of study enrolment.
Exclusion
Key Trial Info
Start Date :
December 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2019
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03796910
Start Date
December 18 2018
End Date
September 24 2019
Last Update
October 28 2019
Active Locations (1)
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1
Simbec Research, Ltd.
Merthyr Tydfil, Mid Glamorgan, United Kingdom, CF48 4DR