PainPhase 1NCT04499209
Pharmacokinetics Study of XG005 Capsule
A Phase 1 study testing XG005 and Combination of Naproxen and Pregabalin in people with Pain, run by Xgene Pharmaceutical Group at 1 site in Australia.
Trial summary
This was a Phase 1, single-center, randomized, placebo-controlled, 2-period, ascending single-dose study assessing the PK, safety, and tolerability of single ascending doses of XG005 (Period 1) and the naproxen and pregabalin combination (Period 2), in 5 dose groups each with 10 subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- XG005 and Combination of Naproxen and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Oct 2017to 19 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI range of 18-30 kg/m2
- Medically healthy subjects
- Creatinine clearance ≥ 80 mL/min
Who cannot join
- History or presence of significant diseases
- History or presence of alcoholism or drug abuse
- Consumption of alcohol 48 hours prior each dose
- Hypersensitivity or idiosyncratic reaction to the study drug
- Abnormal diet (for whatever reason) during the 30 days prior to the first dosing;
- Donation (standard donation amount or more) of blood or blood products
Show all 10Show fewer
- Plasma donation within 7 days prior to the study;
- Participation in another clinical trial within 30 days prior to the first dose;
- Female subjects who are pregnant or lactating;
- Hemoglobin < 120 g/L
Trial locations and contacts
1 site in 1 country.
Australia1 site
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
About this study
Official title: A Phase 1, Single-Center, Randomized, Placebo-Controlled, Ascending Single-Dose Study of the Pharmacokinetics, Safety, and Tolerability of Oral XG005 in Healthy Volunteers
This was a Phase 1, single-center, randomized, placebo-controlled, 2-period, ascending single-dose study assessing the PK, safety, and tolerability of single ascending doses of XG005 (Period 1) and the naproxen and pregabalin combination (Period 2), in 5 dose groups each with 10 subjects.
Read the detailed description
Period 1 was double-blind and randomized 8 subjects (1:1 allocation ratio by gender) to XG005 and 2 subjects (1:1 allocation ratio by gender) to placebo. Subjects were enrolled sequentially into a total of 5 ascending dose levels pending safety review, and PK review where possible, of Period 1 of the prior dose level. Sentinel dose participants (1 for XG005 and 1 for placebo) were included as the first dose administered at each dose level in Period 1.
In Period 2, all subjects in the last three XG005 dose groups received approximate molar equivalents of naproxen and pregabalin corresponding to XG005 doses after a 7-day washout period. Period 2 was open-label with 10 subjects per group.
PK blood samples in each treatment period were collected at 0 (pre-dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs after drug administration.
- Conditions
- Pain
- Being tested
- XG005, Combination of Naproxen and Pregabalin, Placebos
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XG005Drug
XG005 Capsule
Combination of Naproxen and PregabalinDrug
Naproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica
PlacebosDrug
Placebo Capsule
| Study group | Role | What they receive |
|---|---|---|
| Period 1- XG005 | Experimental | XG005 capsule in 4 dose level Receives: Drug: XG005 |
| Period 2- Naproxen and Pregabalin | Active comparator | Combination of Naproxen and Pregabalin Receives: Drug: Combination of Naproxen and Pregabalin |
| Period 1- Placebo | Placebo comparator | XG005 matching placebo Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Measured: Day1 to Day 4
Time to maximum concentration (Tmax)
Measured: Day1 to Day 4
Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
Measured: Day1 to Day 4
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Measured: Day1 to Day 4
Terminal Elimination Rate Constant (kel)
Measured: Day1 to Day 4
Terminal half-life (t1/2)
Measured: Day1 to Day 4
Terminal clearance (CL/F)
Measured: Day1 to Day 4
Volume of distribution (Vd/F)
Measured: Day1 to Day 4
Secondary outcomes (10)
incidence and severity of adverse events (AEs)
Measured: Day -1 to Day 8
blood pressure
vital signs
Measured: Day -1 to Day 8
heart rate
vital signs
Measured: Day -1 to Day 8
respiratory rate
vital signs
Measured: Day -1 to Day 8
temperature
vital signs
Measured: Day -1 to Day 8
physical examination
Cardiovascular, Ears, Nose and Throat, Eyes, Gastrointestinal, Head, Lymph Nodes, Musculoskeletal, Neurological, Respiratory, Skin
Measured: Day -1 to Day 8
electrocardiogram (ECG) parameters;
ECG-PR, RR, QRS, QT, and QTc intervals
Measured: Day -1 to Day 8
clinical laboratory parameters -chemistry
BUN, Creatinine, Total bilirubin, Total protein, Alkaline phosphatase, Uric Acid, Estimated creatinine clearance, Creatine Phosphokinase (CPK), AST (SGOT), ALT (SGPT), Glucose, Sodium, Potassium
Measured: Day -1 to Day 8
clinical laboratory parameters- hematology
Hemoglobin, Hematocrit, Red Blood Cell Count, White Blood Cell Count with differential, Platelet Count
Measured: Day -1 to Day 8
clinical laboratory parameters urinalysis
- pH • Specific gravity • Protein
- Glucose • Ketones • Bilirubin
- Blood • Nitrite • Urobilinogen
- Leukocytes
Measured: Day -1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start16 Oct 2017
- Primary completion18 Jan 2018
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Period 1: ascending single-dose of XG005 vs Placebo; Period 2: combination of Naproxen and Pregabalin
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xgene Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499209
- Sponsor's protocol ID
- XG005-01
- Status last verified
- Aug 2020
- First submitted
- 13 Jul 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Randomized, Placebo-Controlled, Ascending Single-Dose Study of the Pharmacokinetics, Safety, and Tolerability of Oral XG005 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04499209
- Acronym / sponsor ID
- XG005-01
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Xgene Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase 1, single-center, randomized, placebo-controlled, 2-period, ascending single-dose study assessing the PK, safety, and tolerability of single ascending doses of XG005 (Period 1) and the naproxen and pregabalin combination (Period 2), in 5 dose groups each with 10 subjects.
Detailed description
Period 1 was double-blind and randomized 8 subjects (1:1 allocation ratio by gender) to XG005 and 2 subjects (1:1 allocation ratio by gender) to placebo. Subjects were enrolled sequentially into a total of 5 ascending dose levels pending safety review, and PK review where possible, of Period 1 of the prior dose level. Sentinel dose participants (1 for XG005 and 1 for placebo) were included as the first dose administered at each dose level in Period 1.
In Period 2, all subjects in the last three XG005 dose groups received approximate molar equivalents of naproxen and pregabalin corresponding to XG005 doses after a 7-day washout period. Period 2 was open-label with 10 subjects per group.
PK blood samples in each treatment period were collected at 0 (pre-dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs after drug administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Period 1: ascending single-dose of XG005 vs Placebo; Period 2: combination of Naproxen and Pregabalin
| Arm | Type | Receives |
|---|---|---|
| Period 1- XG005 | Experimental | Drug: XG005XG005 capsule in 4 dose level |
| Period 2- Naproxen and Pregabalin | Active comparator | Drug: Combination of Naproxen and PregabalinCombination of Naproxen and Pregabalin |
| Period 1- Placebo | Placebo comparator | Drug: PlacebosXG005 matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI range of 18-30 kg/m2
- Medically healthy subjects
- Creatinine clearance ≥ 80 mL/min
Key exclusion criteria (10 listed)
- History or presence of significant diseases
- History or presence of alcoholism or drug abuse
- Consumption of alcohol 48 hours prior each dose
- Hypersensitivity or idiosyncratic reaction to the study drug
- Abnormal diet (for whatever reason) during the 30 days prior to the first dosing;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XG005XG005 Capsule | Drug | Period 1- XG005 |
| Combination of Naproxen and PregabalinNaproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica | Drug | Period 2- Naproxen and Pregabalin |
| PlacebosPlacebo Capsule | Drug | Period 1- Placebo |
Primary outcome
Maximum concentration (Cmax)
Time frame: Day1 to Day 4
Time to maximum concentration (Tmax)
Time frame: Day1 to Day 4
Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
Time frame: Day1 to Day 4
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: Day1 to Day 4
Terminal Elimination Rate Constant (kel)
Time frame: Day1 to Day 4
Terminal half-life (t1/2)
Time frame: Day1 to Day 4
Terminal clearance (CL/F)
Time frame: Day1 to Day 4
Volume of distribution (Vd/F)
Time frame: Day1 to Day 4
10 secondary outcomes
incidence and severity of adverse events (AEs)
Time frame: Day -1 to Day 8
blood pressure
Time frame: Day -1 to Day 8
heart rate
Time frame: Day -1 to Day 8
respiratory rate
Time frame: Day -1 to Day 8
temperature
Time frame: Day -1 to Day 8
physical examination
Time frame: Day -1 to Day 8
electrocardiogram (ECG) parameters;
Time frame: Day -1 to Day 8
clinical laboratory parameters -chemistry
Time frame: Day -1 to Day 8
clinical laboratory parameters- hematology
Time frame: Day -1 to Day 8
clinical laboratory parameters urinalysis
Time frame: Day -1 to Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XG005 and Combination of Naproxen and Pregabalin in people with Pain, run by Xgene Pharmaceutical Group at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration (Cmax) (time frame: Day1 to Day 4). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020; AzTrials last refreshed its copy on 31 Oct 2026.