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Trial registered on ANZCTR
Registration number
ACTRN12610001080011
Ethics application status
Approved
Date submitted
3/12/2010
Date registered
8/12/2010
Date last updated
24/03/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
An open-labeled, randomized, crossover, single-dose study in healthy male subjects to test the pharmacokinetics (how your body handles the drug e.g. how it absorbs it and how it eliminates it), safety, and tolerability of investigational drugs taken as single agents or as combinations of two investigational drugs, with a pharmacokinetics comparison to the marketed drug Reyataz(Registered Trademark)
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Scientific title
An open-labeled, randomized, crossover, single-dose study in healthy male Participants to evaluate the pharmacokinetics, safety, and tolerability of stable isotopologs of atazanavir (ATV), administered as single agents or as combinations of two isotopologs, with a pharmacokinetic comparison to Reyataz(Registered Trademark)
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Secondary ID [1]
253236
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NIL
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Universal Trial Number (UTN)
NIL
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Trial acronym
NIL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
treatment and prevention of HIV
258767
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Condition category
Condition code
Infection
258912
258912
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0
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Part A participants are permitted to participate in Part B of the study. Their participation is dependant upon availablility. Part A is divided into 3 periods. Each period is separated by a 7 day washout period. 16 Subjects are divided in to Group A1 and A2. Within each group 8 subjects will be randomised to recieve one of the following treatments. Group A1 the 8 subjects are separated into 2 groups of 4. For Period 1, 8 subjects receive C-10276 200mg. For Period 2, 4 subjects will receive C-10276 400mg and 4 subjects will receive Reyataz 400mg. For Period 3 the treatment will crossover and the 4 subjects receiving C-10276 400mg in Period 2 will receive Reyataz 400mg and the 4 subjects receiving Reyataz 400 mg in Period 2 will recieve C-10276 400mg. Group A2 the 8 subjects are separated into 2 groups of 4. For Period 1 8 subjects receive C-10276 300mg. For Period 2, 4 subjects will receive C-10276 400mg and 4 subjects will receive Co-Dose Ratio 1 CTP-518 (100mg): C-10276 (300mg). For Period 3 the treatment will crossover and the 4 subjects receiving C-10276 400mg in Period 2 will receive Co-dose ratio 1 and the 4 subjects receiving Co-dose ratio 1 in Period 2 will recieve C-10276 400mg. Part B is divided in to two sub-parts. The first sub-part consists of two Groups B1 and B2, each group consists of 4 subjects. 4 subjects will receive C-10297 (200 mg) and 4 subjects will receive C-10299 (200 mg). The second sub-part will consist of three groups, B3, B4 and B5. Each group will consist of 8 subjects. These subjects will be dosed over 3 periods. Each period is separated by a 7 day washout period. For Period 1, 8 subjects will receive C-10297 (400 mg), 8 subjects will receive C-10299 (400 mg) and 8 subjects will receive C-10276 (600 mg). For Period 2, all 3 groups of 8 subjects will receive Reyataz (400 mg). For Period 3, 8 subjects will receive C-10297 (600 mg), 8 subjects will receive C-10299 (600 mg) and 8 subjects will receive Reyataz (600 mg). All the Isotopologs will be administered via oral suspension. Reyataz will be administered via oral capsules.
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Intervention code [1]
257705
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Treatment: Drugs
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Intervention code [2]
257716
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Prevention
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Comparator / control treatment
Reyataz (Registered Trademark) (Atazanavir sulphate) – single oral dose 400mg (two 200 mg capsules) and single oral dose 600 mg (two 300 mg capsules)
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Control group
Active
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Outcomes
Primary outcome [1]
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To determine the pharmacokinetic (PK) properties, in healthy male subjects in a fed state, of single oral doses of single-agent Atazanavir (ATV) isotopologs or as combinations of two ATV isotopologs. In Part A, each group will have, 54 PK blood samples collected over the 3 treatment periods for each subject. In Part B, Group B1 and B2 will have 18 PK blood samples collected over the treatment period for each subject. Group B3, B4 and B5 will have 54 PK blood samples collected over the 3 treatment periods for each subject. PK samples for Part A and Part B will be sent to the analytical lab ofr analysis. This data will be reviewed at the end of Period 1 and at the end of Part A of the study. For Part B, the PK data will be reviewed following dosing for Group B1 and B2. For Group B3, B4 and B5, the data will be reviewed at the end of Period 1 and at the end of Part B of the study.
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Assessment method [1]
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Timepoint [1]
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Predose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36 and 48 hours post-dose.
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Secondary outcome [1]
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To compare the PK properties, in healthy male subjects in a fed state, of single oral doses of singleagent ATV isotopologs or as combinations of two ATV isotopologs with the PK properties in the same subjects, in a fed state, of a single 400 mg dose of Reyataz or a single 400 mg dose of C-10276 (Part A). In Part A, each group will have, 54 PK blood samples collected over the 3 treatment periods for each subject. In Part B, Group B1 and B2 will have 18 PK blood samples collected over the treatment period for each subject. Group B3, B4 and B5 will have 54 PK blood samples collected over the 3 treatment periods for each subject. PK samples for Part A and Part B will be sent to the analytical lab ofr analysis. This data will be reviewed at the end of Period 1 and at the end of Part A of the study. For Part B, the PK data will be reviewed following dosing for Group B1 and B2. For Group B3, B4 and B5, the data will be reviewed at the end of Period 1 and at the end of Part B of the study.
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Assessment method [1]
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Timepoint [1]
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Days -1-3, 7-10, 7 - 14 (Follow-up, Group B1 and B2) 14-17 and 22-29 (Follow-up Part A and Group B3, B4 and B5)
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Secondary outcome [2]
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To evaluate the safety and tolerability, in healthy male subjects in a fed state, of single oral doses of single-agent ATV isotopologs and as combinations of two ATV isotopologs.
To assess the safety and tolerability of the study, the Clinical laboratory results, Adverse Events, ECGs and Vital Signs taken and reviewed over the three treatment periods by a medical officer.
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Assessment method [2]
268571
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Timepoint [2]
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Days -1-3, 7-10, 7 - 14 (Follow-up, Group B1 and B2) 14-17 and 22-29 (Follow-up Part A and Group B3, B4 and B5)
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Eligibility
Key inclusion criteria
1. Healthy, as determined by the responsible physician, based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit and prior to the first dose of study drug.
2. Healthy adult males between 18 and 50 years of age, inclusive
3. Body weight greater than or equal to 50 kg and BMI within the range of 18 to 32 kg/m2, inclusive, at screening
4. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and the protocol
5. Negative tests for selected drugs of abuse, cotinine, and alcohol at screening and Day -1
6. Dietary habits that fall within the range of normal, as determined by the investigator. Examples of unusual diets are liquid diets, protein-only diets, high fat-diets, or lowcarbohydrate diets.
8. Willingness of male subjects to abstain from sexual intercourse with pregnant or lactating women; and if engaging in sexual intercourse with a female partner who could become pregnant, a willingness of male subjects to use a condom and spermicide, in addition to having the female partner use another form of contraception such as an intrauterine device, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants, or a tubal ligation. This criterion must be followed from the time of first study drug administration until 30 days after the final administration of study drug.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions
2. PR interval = 220 msec or QRS duration = 120 msec or QT interval > 450 msec obtained at screening visit or prior to the first dose of study drug
3. Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), serum creatinine, or bilirubin > upper limit of normal (ULN) at screening or prior to the first dose of study drug.
4. Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
5. Urinalysis positive for protein or glucose (greater than trace findings of protein or glucose) at screening or prior to the first dose of study drug
6. History of drug abuse within 6 months of screening
7. History of any tobacco product use within 3 months prior to the study,
8. Participation in a clinical trial and receipt of an investigational medication or a new chemical entity within 30 days, 5 half-lives, or twice the duration of the biological effect of any medication (whichever is longer) prior to the first dose of current study drug
9. Use of prescription or non-prescription medications, including herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug, or use of St. John’s Wort within 14 days prior to the first dose of study drug.
10. Consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, or red wine within 7 days prior to administration of study drug
11. Consumption of any caffeine and/or xanthine products (ie, coffee, tea, chocolate and caffeine containing sodas, colas, etc) within 48 hours prior to each dose of study drug and while confined at the clinical site
12. Donation of blood or blood products or blood collection in excess of 470 mL within 8 weeks prior to dosing
13. History of sensitivity to any of the study drugs or components thereof, or a history of medication allergy or other allergy that, in the opinion of the investigator, contraindicates study participation
14. Unwillingness to comply with protocol-specified lifestyle and/or dietary restrictions
15. Major surgery within 4 weeks of screening
16. Uncontrolled intercurrent illness (ie, active infection)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Part A - Period 1: same treatment Period 2 &3: balanced two-way cross-over
Part B - First subpart low dose of two treatments. Second subpart: Period 1 same treatment at different dose levels, Period 2 same treatment and Period 3 partial crossover
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Phase
Phase 1
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Type of endpoint/s
Pharmacokinetics
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
30/11/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
32
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
258173
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Commercial sector/Industry
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Name [1]
258173
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Concert Pharmaceuticals, Inc
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Address [1]
258173
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99 Hayden Avenue,
Suite 500
Lexington, MA, USA 02421
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Country [1]
258173
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Concert Pharmaceuticals, Inc
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Address
99 Hayden Avenue,
Suite 500
Lexington, MA, USA 02421
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
257347
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Country [1]
257347
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Limited
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Ethics committee address [1]
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229 Greenhill Road
Dulwich SA 5065
Australia
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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13/10/2010
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Approval date [1]
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29/11/2010
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Ethics approval number [1]
260162
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2010-10-515
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Summary
Brief summary
In this 2-part study, a total of 48 healthy male subjects will be enrolled and will be randomized to 1 of 8 sequences (4 in each study part), in groups of 4 subjects each. Part A of the study will be a 3-way crossover design. Part A1 will evaluate two single ascending doses of the single agent C-10276 (an ATV isotopolog), and a dose of Reyataz. Part A2 will evaluate the single agent C-10276 at two dose levels and co-administration of CTP-518 and C-10276. Part B will consist of two subparts. In the first subpart, C-10297 and C-10299 will be administered in 200 mg doses, in two groups of 4 subjects each. The second subpart consists of three groups of 8 subjects that will participate in a 3-way partial crossover study design. C-10297 and C-10299 will be administered in 400 and 600 mg doses, C-10276 will be administered in 600 mg and Reyataz will be dosed in 400 and 600 mg doses. All study drug doses, including the comparator, Reyataz, will be administered as single, open-labeled doses to subjects after a light meal. There will be a 7-day washout between individual subjects’ doses.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
31986
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Contact person for public queries
Name
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Samantha Woolman
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Address
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CPR Pharma Services Pty Ltd
Suite C
32 West Thebarton Rd
THEBARTON SA 5031
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Country
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Australia
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Phone
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+61 8 8125 1913
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Fax
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+61 8 8354 3146
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ginny Braman
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Address
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Concert Pharmaceuticals, Inc
99 Hayden Avenue,
Suite 500
Lexington, MA, USA 02421
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Country
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United States of America
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Phone
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+1 781 674 5253
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Fax
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+1 781-674-5353
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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