Single and Multiple Ascending Oral Dose Study of RX-10001 in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Randomized, Double Blind, Placebo Controlled, Ascending Single and Multiple Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Food Effect Study of RX-10001 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941018
• Other study ID #: RX-10001-002
• Status: Completed
• Phase: Phase 1
• First received: July 14, 2009
• Last updated: December 1, 2009
• Start date: June 2009
• Est. completion date: September 2009

Study information

• Verified date: December 2009
• Source: Resolvyx Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to determine the safety, tolerability, pharmacodynamics and pharmacokinetics of RX-10001.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI: 18 - 32 kg/m2, inclusive

• Female subjects: must be of non-childbearing potential (either surgically sterilized or at least 1 year post-menopausal (amenorrhea duration of 12 months)

• Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks") and grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge

• Medical history without major pathology

• Resting supine blood pressure and pulse rate showing no clinically relevant deviations as judged by the MI

• Computerised (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the MI

• All values for hematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the MI

• Willingness to sign the written Informed Consent Form (ICF)

Exclusion Criteria:

• Evidence of clinically relevant pathology

• Mental handicap

• History of relevant drug and/or food allergies

• Regular/routine treatment with non-topical medications within 30 days prior to drug administration

• Use of tobacco products (less than 60 days prior to drug administration)

• History of alcohol abuse or drug addiction (including soft drugs like cannabis products)

• Use of concomitant medication (including over the counter medication, health supplements, multivitamins and vitamin C, vitamin and omega-3 supplements, and herbal remedies such as St. John's Wort extract) must have been stopped at least 14 days prior to the first dose. The use of a limited amount of acetaminophen (paracetamol) is permitted on discretion of the MI.

• Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies in the 10 months preceding the start of this study.

• Donation of more than 100 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 litres of blood in the 10 months preceding the start of this study.

• Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids), barbiturates, benzodiazepines, tricyclic antidepressants and alcohol

• Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)

• Positive screen on HBsAg

• Positive screen on anti HCV

• Positive screen on anti HIV 1/2

• Illness within 5 days prior to (the first) drug administration

• Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a medical trial in the previous year

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• RX-10001
RX-10001 or vehicle control will be administered as an oral solution. Doses will be determined according to the pk results of the preceding cohorts.

Locations

Country	Name	City	State
Netherlands	PRA International	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
Resolvyx Pharmaceuticals, Inc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability following single and multiple ascending oral doses as assessed by adverse events, vital signs, 12-lead ECG, clinical laboratory and physical exam.		1 and 7 days	Yes
Secondary	To determine the pk and pharmacodynamics after single and multiple ascending doses		1 and 7 days	No