Start: June 2016
End: December 2016
What Is This Study About?
In this Phase I study, the experimental drug BPN14770 will be tested to evaluate its safety, tolerability, and pharmacokinetic profile in healthy volunteers. BPN14770 is a potential treatment for memory loss in people with early- to moderate-stage Alzheimer's disease.
Do I Qualify To Participate in This Study?
- Healthy volunteers age of 21 to 45, inclusive, or age 65 and older
- Body mass index of 18-32 kg/m2, inclusive; weight of 50 kg (110 pounds) or more
- Female subjects must be surgically sterile (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to dosing), at least 2 years postmenopausal, or willing to use two barrier methods of contraception (diaphragm, cervical cap, male condom, female condom, and spermicidal foam and sponges) from initial screening until 1 month after taking the last dose of study drug
- Male subjects must be willing to inform female partners of their participation in the study and must agree to use adequate contraceptive methods (vasectomy performed at least 6 months prior to dosing or use at least one barrier method of birth control)
- Willing and able to remain in the study for its duration and return for outpatient visits
Must NOT have:
- Clinically significant abnormality, as indicated by laboratory test results, medical or social history, vital signs, or physical examination
- Positive test results for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- Low blood pressure (systolic blood pressure of 90 mmHg or diastolic blood pressure of 50 mmHg) or high blood pressure (systolic blood pressure of 150 mmHg or diastolic blood pressure of 100 mmHg) at screening or initial dosing visit; stable, well-controlled hypertension and hyperlipidemias are allowed
- Marked bradycardia (heart rate 45 beats/minute) or tachycardia (heart rate 110 beats/minute)
- Current or past history of significant cardiovascular, cerebrovascular, pulmonary, renal, or liver disease
- History of hematological disorders such as thrombocytopenia in the immediate family (parents and siblings)
- Clinically important or significant abnormalities on single ECG or evidence or history of long QT syndrome
- Current or past history of gastric or duodenal ulcers or other diseases of the gastrointestinal tract that could interfere with absorption of study drug
- Active acute or chronic infectious diseases
- Taking psychotropic drugs, sedative antihistamines, or other centrally active medications; moderate to strong inhibitors or inducers of CYP3A4, CYP2D6, or other cytochromes
- History of alcohol or drug abuse within the year prior to screening; daily consumption of alcohol exceeding two bottles of beer or equivalent (1 serving = 12 oz. beer, 5 oz. wine, or 1.5 oz. distilled spirits); positive screen for drugs of abuse
- Active smokers or tobacco users who cannot discontinue tobacco use at least 3 months prior to starting study or refrain from using tobacco during the study
- Participation in other clinical studies involving investigational drug within 30 days prior to screening
- Donation of blood or blood products during the 8 weeks before first administration of study drug
- History of allergy to penicillin or sulfonamides, or any other clinically significant drug allergy
- Inability or unwillingness to perform cognitive testing
- Suicidal ideation and/or any suicidal behavior within the past 30 days
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Tetra Discovery Partners
Source: ClinicalTrials.gov ID: NCT02840279