Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Camlipixant · 4 trials · 3 indications
Participants rate their pain intensity daily on a numeric rating scale from 0 (no pain) to 10 (worst possible pain). Weekly API scores are derived by averaging daily API scores. Higher score indicates worst outcome. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Dabigatran. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
Blood samples were collected at indicated time points for PK analysis of Camlipixant. PK analysis was conducted using standard non-compartmental methods.
| Arm | Type | Description |
|---|---|---|
| Placebo/Placebo or Camlipixant | PLACEBO_COMPARATOR | Participants will receive placebo in Part A and Placebo or Camlipixant in Part B. |
| Camlipixant dose level 1/Placebo or Camlipixant | EXPERIMENTAL | Participants will receive Camlipixant dose level 1 in Part A and Placebo or Camlipixant in Part B. |
| Camlipixant dose level 2/Placebo or Camlipixant | EXPERIMENTAL | Participants will receive Camlipixant dose level 2 in Part A and Placebo or Camlipixant in Part B. |
| Camlipixant dose level 3/Placebo or Camlipixant | EXPERIMENTAL | Participants will receive Camlipixant dose level 3 in Part A and Placebo or Camlipixant in Part B |
| Part 1: Moderate HI Participants | EXPERIMENTAL | Participants with moderate HI received a single dose of camlipixant 50 milligrams (mg) tablet orally on Day 1 in the fasted state. |
| Part 1: Matched Healthy Participants to Moderate HI | EXPERIMENTAL | Healthy participants (matched to participants with moderate HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
| Part 2: Severe HI Participants | EXPERIMENTAL | Participants with severe HI received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
| Part 2: Matched Healthy Participants to Severe HI | EXPERIMENTAL | Healthy participants (matched to participants with severe HI) received a single dose of camlipixant 50 mg tablet orally on Day 1 in the fasted state. |
| Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | EXPERIMENTAL | Participants received a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses of gemfibrozil 600 mg tablet twice daily (BID), every 12 hours, (total daily dose of 1200 mg) on Days 5 to 11, with co-administration of a single oral dose of camlipixant 50 mg tablet with the gemfibrozil on Day 9. There was a washout of at least 4 days between the dose of camlipixant on Day 1 and the dose of gemfibrozil on Day 5. |
| Part 2: Dabigatran etexilate 150 mg + camlipixant 50 mg | EXPERIMENTAL | Participants received single oral dose of dabigatran etexilate 150 mg capsule on Day 1, followed by repeated oral doses of camlipixant 50 mg tablet twice daily (BID) (total daily dose of 100 mg) from Days 5 to 9, with co-administration of a single oral dose of dabigatran etexilate 150 mg capsule with the morning dose of camlipixant on Day 10. There was a washout of at least 4 days between the dose of dabigatran etexilate on Day 1 and the dose of camlipixant on Day 5. |
| Part 1: Camlipixant 50 mg + Rifampin 600 mg | EXPERIMENTAL | Participants will receive a single oral dose of camlipixant 50 milligram (mg) tablet on Day 1, followed by repeat oral doses (2\*300 mg) of rifampin 600 mg capsules, once daily (QD) from Days 4 to 12, with co-administration of a single oral dose of 50 mg camlipixant tablet with rifampin capsules on Day 11. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rifampin on Day 4. |
| Part 2: Camlipixant 50 mg + Rabeprazole 20 mg | EXPERIMENTAL | Participants will receive a single oral dose of camlipixant 50 mg tablet on Day 1, followed by repeat oral doses of 20 mg rabeprazole enteric-coated tablets, once daily (QD) from Days 4 to 11, with co-administration of a single oral dose of 50 mg camlipixant tablet with rabeprazole enteric-coated tablet on Day 10. There will be a washout of at least 3 days between the dose of camlipixant on Day 1 and the dose of rabeprazole on Day 4 |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo to be administered |
| Camlipixant | DRUG | Camlipixant to be administered |
| Dabigatran etexilate | DRUG | Dabigatran etexilate will be administered |
| Gemfibrozil | DRUG | Gemfibrozil will be administered. |
| Rabeprazole | DRUG | Rabeprazole will be administered |
| Rifampin | DRUG | Rifampin will be administered. |
Inclusion Criteria: * Male or female aged 18 to 80 years inclusive, at the time of signing the Informed consent form (ICF). * Diagnosis of IBS-D or IBS-M according to the Rome IV criteria at screening * Moderate or severe irritable bowel syndrome (IBS) based on Irritable bowel syndrome Severity Sco...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Eluxadoline |
| Ardelyx, Inc. | ARDX | 3 | PHASE3 | Tenapanor |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | - | Undisclosed |
| Johnson & Johnson | JNJ | 1 | - | Anti TNF therapy including infliximab, No Biologics |
| Cooper Companies, Inc. | COO | 1 | N/A | Undisclosed |
Camlipixant is an investigational small molecule being studied for cough and irritable bowel syndrome (IBS). It is in clinical development for these conditions, including a Phase 2 trial in adults with IBS with diarrhea (IBS-D) and IBS with mixed bowel habits (IBS-M). It is not approved by the FDA.
Camlipixant is being developed by GSK plc, a global biopharma company listed on the New York Stock Exchange under the ticker GSK. GSK is conducting clinical trials of Camlipixant in healthy volunteers and in patients with cough and irritable bowel syndrome.
Camlipixant is in Phase 1 and Phase 2 clinical development. Phase 1 trials have been completed in healthy participants and in participants with hepatic impairment, and a Phase 2 trial is currently recruiting participants with irritable bowel syndrome. Camlipixant is investigational and not yet approved.
Camlipixant has been studied in several clinical trials. Completed Phase 1 trials include NCT05899829, NCT05959447, and NCT06222892, which evaluated drug interactions and the effects of hepatic impairment. A Phase 2 trial, NCT07519395, is recruiting adults with irritable bowel syndrome with diarrhea or mixed bowel habits.
Yes, Camlipixant has been studied in healthy volunteers in several Phase 1 trials. These trials, conducted in Canada and the United States, enrolled healthy participants to evaluate drug interactions and pharmacokinetics. One trial also included participants with hepatic impairment.
The Phase 2 trial of Camlipixant, NCT07519395, is studying abdominal symptoms in adults with irritable bowel syndrome with diarrhea (IBS-D) and irritable bowel syndrome with mixed bowel habits (IBS-M). This randomized, controlled trial is recruiting 420 participants in the United States.