Phase 1 Study of NPT200-11 in Healthy Subjects

NCT ID: NCT02606682

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-02-29

Brief Summary

The purpose of this study is to determine the safety, tolerability and blood levels of orally administered NPT200-11 in healthy subjects. In addition, the maximally tolerated dose will be determined.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NPT200-11 - Cohort 1, Dose 1

Single ascending dose of orally administered capsule(s) NPT200-11: 15 mg OR Single dose of orally administered placebo capsule(s) to match dose

Group Type: EXPERIMENTAL

NPT200-11

Intervention Type: DRUG

Single doses of NPT200-11capsules, orally administered

Placebo

Intervention Type: DRUG

Single doses of microcrystalline cellulose capsules, orally administered

NPT200-11 - Cohort 2, Dose 2

Single ascending dose of orally administered capsule(s) NPT200-11: 30 mg OR Single dose of orally administered placebo capsule(s) to match dose

Group Type: EXPERIMENTAL

NPT200-11

Intervention Type: DRUG

Single doses of NPT200-11capsules, orally administered

Placebo

Intervention Type: DRUG

Single doses of microcrystalline cellulose capsules, orally administered

NPT200-11 - Cohort 3, Dose 3

Single ascending dose of orally administered capsule(s) NPT200-11: 60 mg OR Single dose of orally administered placebo capsule(s) to match dose

Group Type: EXPERIMENTAL

NPT200-11

Intervention Type: DRUG

Single doses of NPT200-11capsules, orally administered

Placebo

Intervention Type: DRUG

Single doses of microcrystalline cellulose capsules, orally administered

NPT200-11 - Cohort 4, Dose 4

Single ascending dose of orally administered capsule(s) NPT200-11: 120 mg OR Single dose of orally administered placebo capsule(s) to match dose

Group Type: EXPERIMENTAL

NPT200-11

Intervention Type: DRUG

Single doses of NPT200-11capsules, orally administered

Placebo

Intervention Type: DRUG

Single doses of microcrystalline cellulose capsules, orally administered

NPT200-11 - Cohort 5 ,Dose 5

Single ascending dose of orally administered capsule(s) NPT200-11: 240 mg OR Single dose of orally administered placebo capsule(s) to match dose

Group Type: EXPERIMENTAL

NPT200-11

Intervention Type: DRUG

Single doses of NPT200-11capsules, orally administered

Placebo

Intervention Type: DRUG

Single doses of microcrystalline cellulose capsules, orally administered

NPT200-11 -Cohort 6, Dose 6

Single ascending dose of orally administered capsule(s) NPT200-11: 360 mg OR Single dose of orally administered placebo capsule(s) to match dose

Group Type: EXPERIMENTAL

NPT200-11

Intervention Type: DRUG

Single doses of NPT200-11capsules, orally administered

Placebo

Intervention Type: DRUG

Single doses of microcrystalline cellulose capsules, orally administered

NPT200-11 - Cohort 7, Dose 7

Single ascending dose of orally administered capsule(s) NPT200-11: 480 mg OR Single dose of orally administered placebo capsule(s) to match dose

Group Type: EXPERIMENTAL

NPT200-11

Intervention Type: DRUG

Single doses of NPT200-11capsules, orally administered

Placebo

Intervention Type: DRUG

Single doses of microcrystalline cellulose capsules, orally administered

Interventions

NPT200-11

Single doses of NPT200-11capsules, orally administered

Intervention Type: DRUG

Placebo

Single doses of microcrystalline cellulose capsules, orally administered

Intervention Type: DRUG

Other Intervention Names

Microcrystalline cellulose capsules

Eligibility Criteria

Inclusion Criteria

1. informed of, and willing and able to comply with, all of the protocol requirements and the investigational nature of the study, and have signed an informed consent form in accordance with institutional and regulatory guidelines;

2. male or female adults between 18 and 55 years of age, inclusive;

3. female subjects must be post-menopausal for at least 2 years or surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation);

4. male subjects must be willing to use an adequate barrier method of contraception for the duration of the study and for 90 days after dosing and no sperm donations for the duration of the study and for 90 days after dosing. Male subjects who are surgically sterile need not employ a method of contraception;

5. non-smokers for at least six months;

6. BMI = 18 - 30 kg/m2, inclusive;

7. in good health, in the judgment of the Principal Investigator, as determined by:

• medical history indicative of no serious or severe chronic conditions requiring frequent medical intervention or continual pharmacologic management, and no medical or social conditions that would potentially interfere with the subject's ability to comply with the study visit schedule or the study assessments;
• no clinically significant abnormalities in body temperature, heart rate, respiratory rate, blood pressure;
• no clinically significant abnormalities in the 12-lead electrocardiogram (ECG);
• no clinically significant abnormalities in clinical chemistry (ALT, AST, total bilirubin must be at or below the upper limit of normal and eGFR must be above 90 mL/min), hematology (hemoglobin ≥ 12.0 g/dL), coagulation and urinalysis; lab tests may be repeated, if necessary (details are provided in the attached flow chart of study assessments).

8. negative results on the following screening laboratory tests: urine drug screen, urine alcohol screen, serum pregnancy test, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody.

Exclusion Criteria

• females of child bearing potential;
• history of a significant medical condition that may interfere with absorption, distribution or elimination of NPT200-11, or with the clinical and laboratory safety assessments in this study;
• history of drug hypersensitivity and disorders affecting respiratory function (e.g., COPD, asthma) and cardiac disorders predisposing to cardiac adverse events;
• history of or current alcohol abuse and/or other drug addiction < 2 years prior to screening, or a positive urine drug or alcohol screen (e.g., amphetamines, barbiturates, benzodiazepines, opiates, cannabinoids, alcohol and cocaine);
• positive for HBVsAg, HCV Ab, HIV Ab;
• 12 lead ECG showing the following: having a corrected QTc interval > 450 msec or <320 msec (Fridericia's correction);
• sustained sitting systolic blood pressure > 140 or < 90 mm Hg or sitting diastolic blood pressure > 90 or < 50 mm Hg at Screening or Day -1 (sentinel pair) or Day 1 (remaining 6 subjects in the cohort), the average of the 2 assessments of BP taken at each visit will be used to exclude a subject;
• resting pulse rate at screening of > 100 or < 45;
• donated or lost > 500 mL of blood < 56 days prior to enrollment into this study;
• plasma donation within 7 days prior to enrollment into this study;
• active infection or febrile illness < 14 days prior to the first dose of study medication;
• use of prescription or over-the-counter medications or herbal supplements ≤ 14 days prior to dosing and until completion of follow-up visit on Day 7;
• have participated in other clinical studies of a new chemical entity within 30 days prior to admission to the CRU.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCB S.A. - Pharma Sector

INDUSTRY

Sponsor Role: collaborator

Neuropore Therapies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Armas, M.D. CPI

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

Celerion, Inc

Tempe, Arizona, United States

Countries

United States

Other Identifiers

NPT200-11-001

Identifier Type: -

Identifier Source: org_study_id