Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as NKTR118 Formulation 1, NKTR118 Formulation 2, NKTR118 Formulation 3, NKTR118 Group 2, [14C] NKTR-118
NKTR-118 · 8 trials · 6 indications
The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.
Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week. Baseline was defined as the average SBMs/week during the 2-week OIC screening period. An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.
| Arm | Type | Description |
|---|---|---|
| NKTR-118 12.5mg | EXPERIMENTAL | - |
| NKTR-118 25mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | Oral Treatment |
| 2 | ACTIVE_COMPARATOR | Oral treatment |
| 3 | PLACEBO_COMPARATOR | Oral treatment |
| A | PLACEBO_COMPARATOR | Placebo |
| B | EXPERIMENTAL | NKTR-118 |
| NKTR-118 | EXPERIMENTAL | Single dose NKTR-118 25 mg on Day 1 only |
| Rifampin | ACTIVE_COMPARATOR | Rifampin 600 mg once daily on Days 4 to 12 |
| Rifampin/ NKTR-118 | ACTIVE_COMPARATOR | Rifampin 600 mg plus NKTR-118 25 mg on Day 13 |
| Group 1 | EXPERIMENTAL | Normal hepatic function, 25 mg NKTR-118 administered orally |
| Group 2 | EXPERIMENTAL | Mild hepatic impairment, 25 mg NKTR-118 administered orally |
| Group 3 | EXPERIMENTAL | Moderate hepatic impairment, 25 mg NKTR-118 administered orally |
| C | PLACEBO_COMPARATOR | NKTR-118 placebo (6x placebo tablets) |
| D | ACTIVE_COMPARATOR | Moxifloxacin (1 x 400 mg tablet) |
| Name | Type | Description |
|---|---|---|
| NKTR-118 | DRUG | 12.5 mg oral tablet once daily |
| Placebo | DRUG | Oral tablet intake once daily |
| Usual care | DRUG | As prescribed by the investigator |
| Rifampin | DRUG | Oral 600 mg |
| moxifloxacin | DRUG | 400 mg tablet |
Inclusion Criteria: * Must have completed the 12-week study D3820C00004 through Visit 8. * Provision of written informed consent prior to any study-specific procedures. * Men and women who were between the ages of \>18 and \<85 years at the time of the screening visit for study D3820C00004. * Conti...
NKTR-118 is an investigational small molecule drug developed by AstraZeneca PLC (ticker AZN). It has been studied in conditions including opioid induced constipation (OIC), drug induced constipation, and hepatic functional disturbance. It is also studied for the amount of NKTR-118 in blood. Development has reached Phase 1, and it is not an approved medicine.
NKTR-118 has been studied for opioid induced constipation (OIC) in patients with non-cancer-related pain, for drug induced constipation, and for hepatic functional disturbance. Trials have also assessed the amount of NKTR-118 in blood. These are investigational uses, and NKTR-118 is not an approved treatment for any indication.
NKTR-118 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical trial program for the drug, including pharmacokinetic studies in healthy volunteers and patients with impaired hepatic function, as well as Phase 3 studies in opioid induced constipation.
NKTR-118 is in Phase 1 development. Five clinical trials have been completed, including Phase 1 pharmacokinetic studies and Phase 3 studies in opioid induced constipation, with no active trials currently listed. NKTR-118 is investigational and has not been approved by the FDA.
Completed NKTR-118 trials include NCT01533870, a Phase 1 study of rifampin effects on pharmacokinetics in healthy volunteers; NCT01392807, a Phase 1 pharmacokinetic study in patients with impaired hepatic function; NCT01395524, a Phase 3 extension study in opioid induced constipation; and NCT01336205, a Phase 3 long-term safety study. Total enrollment across the program was 2,705 participants.
Yes, NKTR-118 is also known as NKTR118. Other recorded names include NKTR118 Formulation 1, NKTR118 Formulation 2, NKTR118 Formulation 3, NKTR118 Group 2, and [14C] NKTR-118. These refer to the same investigational compound developed by AstraZeneca PLC under the ticker AZN.