AMAP102 - Safety, Tolerability and Pharmacokinetics in Healthy Subjects

This study has been terminated.
(Reached sufficient pharmacokinetic exposures)
Sponsor:
Information provided by:
AnaMar Medical AB
ClinicalTrials.gov Identifier:
NCT00995605
First received: October 13, 2009
Last updated: October 14, 2009
Last verified: October 2009
  Purpose

The purpose of this study is to determine whether AMAP102 is safe and well tolerated by humans.


Condition Intervention Phase
Healthy Volunteers
Drug: AMAP102
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AMAP102 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetics Study in Healthy Subjects

Further study details as provided by AnaMar Medical AB:

Primary Outcome Measures:
  • Safety and tolerability determined by adverse events, vital signs, ECG and clinical laboratory evaluations [ Time Frame: During residential period and at follow up visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Investigate the pharmacokinetic profile of AMAP102 after one oral dose and after multiple oral doses during twice daily dosing for seven days, and compare the pharmacokinetic profile for men and women [ Time Frame: PK sampling at defined timepoints during residential period ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Groups SAD
AMAP102 or Placebo as single ascending doses in five groups
Drug: AMAP102
AMAP102 or Placebo
Experimental: Groups MAD
AMAP102 or Placebo as multiple ascending doses twice daily for seven days in two groups
Drug: AMAP102
AMAP102 or Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. In Groups A, B, D, E and F, subjects will be males of any ethnic origin between 18 and 65 years of with a BMI between 20.0 and 30.0 kg/m2
  2. In Group C, subjects will be females (of non-childbearing potential) of any ethnic origin between 18 and 65 years with a BMI between 20.0 and 28.0 kg/m2
  3. For Group C, women will be of non-childbearing potential, defined as surgically sterile or post-menopausal, non-lactating and having a negative serum pregnancy test
  4. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations
  5. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions

Exclusion Criteria:

  1. Male subjects who are not willing to use appropriate contraception from the time of the first dose until 3 months after the final dosing occasion
  2. Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration
  3. Subjects who have used any non-prescribed systemic or topical medication within 7 days of the first dose administration
  4. Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration
  5. Subjects who are still participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug in the past 3 months
  6. Subjects who have donated any blood, plasma or platelets in the month prior to screening or who have made donations on more than two occasions within the 12 months preceding the first dose administration
  7. Subjects with a significant history of drug allergy as determined by the Investigator
  8. Subjects who have any clinically significant allergic disease as determined by the Investigator
  9. Subjects who have a supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively
  10. Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits)
  11. Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day
  12. Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders as determined by the Investigator
  13. Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator
  14. Subjects who are known to have serum hepatitis, or who are carriers of the HBsAg or hepatitis C antibody, or who have a positive result to the test for HIV antibodies
  15. Subjects who have an abnormality in the 12-lead ECG such that, in the opinion of the investigator, increases the risk of participating in the study, such as QTc(b) interval greater than 430 msec (male) or greater than 450 msec (female), 2nd or 3rd degree Atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolff-Parkinson-White Syndrome, defined as PR shorter than 110 msec, confirmed by a repeat ECG
  16. Subjects with a significant cardiac history (e.g. heart failure, hypokalemia, long QT syndrome), significant history of fainting, syncope or family history of sudden cardiac death
  17. Subjects who, in the opinion of the Investigator, should not participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995605

Locations
United Kingdom
Covance Clinical Research Unit Ltd.
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
AnaMar Medical AB
Investigators
Principal Investigator: Dr Joseph Chiesa, MD FFPM FICR CSci Covance Clinical Research Unit Ltd.
  More Information

No publications provided

Responsible Party: Clinical Manager
ClinicalTrials.gov Identifier: NCT00995605     History of Changes
Other Study ID Numbers: 102-240-01, 2008-004940-35, 2704-026
Study First Received: October 13, 2009
Last Updated: October 14, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on August 01, 2014