NCT01406925CompletedPhase 1
A Randomised, Placebo-controlled, Double-blind, Cross-over Study in Healthy Men and Women to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intra-anal Doses of NRL001 for Three Doses Using a Cream Formulation Relative to a Matched Placebo Formulation for Reference
Norgine1 site in 1 country12 target enrollmentStarted: April 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Cmax of NRL001
Study Overview
Brief Summary
This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •IN.1) sex: male and female (non-child-bearing potential or using medically adequate contraception
- •IN.2) race: Caucasian
- •IN.3) BW: 50 - 100 kg
- •IN.4) BMI: 20 - 28 kg.m-2
- •IN.5) age: 21 - 50 years
- •IN.6) type: healthy on the basis of specified criteria evaluated at the screening visit
- •IN.7) willing and able to provide informed consent
Exclusion Criteria
- •EX.1) Previous participation in the trial
- •EX.2) Participant in any other trial during the last 90 days
- •EX.3) Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
- •EX.4) History of any clinically relevant allergy (including hypersensitivity to the trial medications)
- •EX.5) Presence of acute or chronic infection
- •EX.6) Presence or history of any relevant co-morbidity
- •EX.7) Resting systolic blood pressure > 140 or < 90 mmHg, diastolic blood pressure > 95 or < 50 mmHg
- •EX.8) Clinically relevant ECG-abnormalities, prolonged QTc with > 450 msec in males and > 460 msec in females in particular
- •EX.9) Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
- •EX.10) Positive serology for HBsAg, anti HBc and anti HCV
- •EX.11) Positive HIV test
- •EX.12) Positive alcohol or urine drug test on recruitment (and upon admission)
- •EX.13) History of alcohol and/or drug abuse and/or daily use of > 30 gr alcohol
- •EX.14) Smoking more than 15 cigarettes/day or equivalent of other tobacco products
- •EX.15) Use of prohibited medication
- •EX.16) Suspicion or evidence that the subject is not trustworthy and reliable
- •EX.17) Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard
- •General - all females
- •EX.18) Positive pregnancy test
- •EX.19) Lactating
- •EX.20) Not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods [condom, diaphragm with spermicidal gel] should be used in addition).
Arms & Interventions
Intermediate dose NRL001
Experimental
0.75% NRL001 cream
Intervention: NRL001 cream (Drug)
Control
Placebo Comparator
Placebo control
Intervention: Placebo control (Drug)
Low dose NRL001
Experimental
0.5% NRL001 cream
Intervention: NRL001 cream (Drug)
High dose NRL001
Experimental
1.0% NRL001 cream
Intervention: NRL001 cream (Drug)
Outcomes
Primary Outcomes
Cmax of NRL001
Time Frame: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing
Secondary Outcomes
- AUC of NRL001(30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing)
- Tolerability of NRL001(Up to 12 hours post-dosing)
Investigators
Study Sites (1)
Loading locations...
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